The effectiveness of routine physiotherapy with and without neuromobilization on pain and functional disability in patients with shoulder impingement syndrome; a randomized control clinical trial.

BACKGROUND: The objective of the study was to compare the effects of neuromobilization (NM) techniques and routine physiotherapy on pain and functional disability in patients having shoulder impingement syndrome (SIS). Present study was aimed to discover evidence based conservative and cost effective remedy on pain and functional disability. STUDY
DESIGN: Single blinded randomized control clinical trial.
METHODS: A total of 80 patients with SIS were randomly assigned into care and experimental groups (40 in each group). After the baseline assessment routine physiotherapy was executed on both groups, while NM was applied additionally to experimental group. Pain and functional disability score were evaluated by Visual Analogue Scale and University of California at Los Angeles rating score at baseline, 5th and 11th week. Differences in outcome between groups were evaluated with clinical improvement.
RESULTS: The experimental group compared with care group at 11th week had lower mean pain score 2.15(1.66-2.64) vs 4.90(4.41-5.40); between group difference, 1.82; 95% (CI), - 2.38 to - 1.25; P < 0.001 and Partial ƞ2 = 0.33, similarly functional disability score 28.58(27.32-29.83) vs 20.10(18.84-21.36); between group difference,5.62; 95%CI, (4.32-6.92); P< 0.001 and Partial ƞ2 = 0.49 respectively. In experimental group NM was a more effective technique to reduce the pain severity and disability in SIS patients as compare to care group.
CONCLUSION: Neuromobilization techniques in addition to routine physiotherapy were significantly effective for the treatment of SIS. TRIAL REGISTRATION: IRCT20190121042445N1 , Registered 19 February 2019.

RCT Entities:   Population Interventions Outcomes

Background

The shoulder impingement syndrome (SIS) consists of the rotator cuff tendonitis and bursitis of the shoulder [1]. It shows the inflammation of the supraspinatus tendon inside the anteroinferior junction of the acromion and the greater tuberosity of the humerus. Patients with SIS report severe acute pain which increases during overhead activities as well as sleeping on affected side [2].

SIS comprises of three stages, the 1st stage is defined by edema and hemorrhage of the subacromial bursa and rotator cuff muscle; it has been detected in patients where age group is less than 25 years. The next stage indicates irreversible changes, which are fibrosis combine with tendinopathy of the rotator cuff muscle. It is highly prevalent among 25 to 40 years old population. At 3rd stage impingement is evident by more severe changes, like partial or complete tears of the rotator cuff, mostly observed among patients who are above 40 years age [3, 4].

The execution of specific components of body movements to generate particular mechanical incident in the neural system is called NM. Mechanical management may therefore be used to augment physiology in the nervous system [5].

It has already been observed that there are three theories projected for the local etiological origin of tendon pain: 1-mechanical, 2-vascular and 3- neural [6, 7].

Mechanical and vascular theories are regularly used for the treatment of tendon pain. The mechanical theory is based on the idea of mechanical overload of the tendon resulting in damage to the collagen. Tendons that receive high strain loads such as the Achilles are often loaded during movement and have been suggested to sustain physiological strain up to 6–8%.

The vascular theory is based on the concept that tendon may experience vascular compromise and neurovascularization. Due to lack of vascularity, the tendon is not capable of healing because of repetitive high strain load. A study conducted by Rees JD et al. observed mechanical, vascular and neural theories which have proposed for tendinopathy and point out the potential appropriate use of NM. The use of NM has the potential to lessen the perception of pain. The movement of the nervous system during NM may restore axoplasm flow, restoring nutrients to the nerves. The restoration of nerve function may then lessen sensitivity (i.e ion channels) to the area and restore normal blood flow to the tendon [7].

Physiologically we may explain that a nerve which closely passes to a joint is mostly kept in a tunnel or it is attached with collagen fibres or fascia to the nearby musculoskeletal components. Nerves move side by side within the upper limb hence the neuromobilization given during management cause break of the cross linkages. The possible effect of stretch on axons is the improved ion flux in stretch sensitive ion channels. The mechanical stimulation used at low frequency, low intensity ultrasound is indicated to arouse neurons in mouse brain by activating voltage gated sodium and calcium channels. The slow elongation can cause structural changes in myelin sheath, axon regeneration, deposition of endoneurial collagen. The nodes of ranvier can open further as it causes the Schmidt- Lanterman clefts which affects the levels of local cytoplasm [8].

The neural component is over looked due to poor outcomes among patients with tendinopathy. Matocha MA et al. highlighted neural involvement in patients with tendon pain and discussed the role of NM for tendon pain [9]. The utilization of neurodynamics may be important for the treatment purposes in patients who suffer with tendonopathies which has neural component [6, 10].

Objective

The objective of the study was to compare the effects of NM techniques and routine physiotherapy on pain and functional disability in patients having SIS. Present study was aimed to discover evidence based conservative and cost effective remedy on pain and functional disability.

Methods

Trial design

The model of study was single blinded randomized controlled clinical trial. This controlled trial used a parallel design where patients were allotted by 1:1 ratio in two groups’ experimental group as well as care group. These patients had gone through a complete systemic physical examination that included the whole neurologic and musculoskeletal assessments. Patients with history of shoulder surgery, shoulder injury, trauma, shoulder joint dislocation, cervical radioculopathy and having other systemic diseases were excluded from the study. The patients with positive upper limb tension test [11], Neer test [3, 4], Hawkins Kennedy [12] Empty Can [12], painful arc and cross body adduction test [13] were included for study.

Randomization

A sample of 80 participants was selected and allocated in to two groups experimental and care group by using computer generator method in simple random sampling technique.

Blinding

An independent assessor, who specialized in musculoskeletal injuries with more than 5 year experience of dealing patients with shoulder injury, had performed allocation of patients.

Participants

Diagnosed patients with SIS was participated in this research. The study purpose was described to all patients and informed consent was taken from them. After approval from Institutional Review Board “The University of Lahore” and present study was completed at physiotherapy department of Social Security Hospital Gujranwala.

Procedures

After initial assessment, the investigator used to take demographic details of the participants along with visual analogue scale (VAS) and functional disability rating score.

All the patient related information was kept confidential and they were free to quit the study at anytime.

VAS was used to evaluate the severity of pain and it was considered as primary outcome of the current study. A constant scale had been employed to inquire the patients about the shoulder pain during the activity and to classify it by indicating on a 10-mm line; it was connected “no pain” and the “worst pain you have ever felt”. This is common method of evaluating severity of shoulder pain. The findings of the study indicate the VAS is a high reliable as well as valid method to assess the severity of pain [14]. The UCLA score was used to assess functional disability and it has total 35 points, with higher values indicating better shoulder condition. The UCLA score has 5 domains; pain 10 points, function 10 points, active forward flexion 5 points, strength of forward flexion 5 points and satisfaction of the patient 5 points [15]. The score was assessed at base line, 5th and 11th week. The internal consistency or reliability of UCLA was 0.78 to 0.89 and 0.51 to 0.59 for post surgical and non surgical respectively.

Interventions

Routine physiotherapy was performed on both groups while NM was done on experimental group. Patients were treated thrice a week on alternative days.

Routine physical therapy

The routine Physiotherapy consisted of pulsed Short Wave Diathermy (SWD) with frequency 27.12 MHZ [16], Ultrasonic Therapy (US) with frequency 1.0 MHZ and intensity 1.45w/cm2 [17] and Transcutaneous Electrical Nerve Stimulator (TENS) 2–200 HZ with output current < 20 Ma width 200 μ seconds along with continuous mode. Exercises were comprised of shoulder strengthing and stretching exercises that were performed for 5 s with 10 repetitions for both experimental and care groups as shown in Table 1 [18].

Table 1

List of exercises performed under experimental and routine physiotherapy group

Experimental group (stretching and strengthing exercises + neuromobilization)

Routine physiotherapy group (stretching and strengthing exercises)

1) STRETCHING EXERCISES a) Shoulder external rotation stretch b) Cross body posterior stretch c) Stretch for anterior aspect of shoulder d) Shoulder flexion stretch 2) STRENGTHING EXERCISES a) Chair press b) Restricted scapular retraction c) Restricted scapular protraction d) Shoulder abduction “Scaption” (0o-90o) with theraband e) Shoulder scapular extension with theraband 3) NEUROMOBILIZATION EXERCISES a) Neural slider technique b) Neural tensioner technique

1) STRETCHING EXERCISES a) Shoulder external rotation stretch b) Cross body posterior stretch c) Stretch for anterior aspect of shoulder d) Shoulder flexion stretch 2) STRENGTHING EXERCISES a) Chair press b) Restricted scapular retraction c) Restricted scapular protraction d) Shoulder abduction “Scaption” (0o-90o) with theraband e) Shoulder scapular extension with theraband

Neuromobilization

NM was applied by using Butler’s recommendations [19]. Initially, the patient performed neural sliders and gradually progressed to neural tensioners. Neural sliders consisted of cervical lateral flexion movement, toward the involved side, simultaneously with elbow flexion and extension movements. While moving the head in to cervical lateral flexion the elbow was extended. When the elbow began to flex, the cervical spine was returned to neutral position as shown in Figs. 1 and 2. Neural tensioners were performed to create tension in the nerve to get the desired results. The tension position was not held for a length of time, but is released by extending the elbow and returning the cervical spine to neutral. Once the patient had pushed slight pain or discomfort at any point as shown in Figs. 3 and 4 [20]. NM technique was performed for 5 s with 10 repetitions to control the pain and improve the functional disability score to relive the pain shown in Table 1.

Fig. 1

Neural slider starting position with elbow flexion

Fig. 2

Neural slider final position with cervical flexion along with elbow extension

Fig. 3

Neural tensioner starting position cervical lateral flexion and elbow flexion

Fig. 4

Neural tensioner final position extending the elbow and returning the cervical spine in neutral

Outcome measures

As an outcome measure for pain severity (0 = no pain and 10 = severe pain) VAS was used with reliability 0.94 at baseline, 5th and 11th week [14]. Pain was considered as primary outcome.

UCLA score was assessed at baseline, 5th and 11th week. The UCLA score was used to assess functional disability and it has total 35 points, with higher values indicating better shoulder condition. The UCLA score has 5 domains; pain 10 points, function 10 points, active forward flexion 5 points, strength of forward flexion 5 points and satisfaction of the patient 5 points [15]. The score was assessed at base line 5th and 11th week. The internal consistency or reliability of UCLA was 0.78 to 0.89 and 0.51 to 0.59 for post surgical and non surgical respectively. The UCLA score was considered as secondary outcome.

Sample size

Sample size calculation was derived from Yamany AA et al. study [21]. According to clinical trials, the sample size estimation formula was implemented [22].

Where SD = Standard deviation = 14.08, Z1 −  is type 1 error = 1.96, Zβ = 0.84, d = μ2 − μ1 = 10.7.

Based on this a total sample size of around 80(experimental = 40, care = 40) was calculated to be an adequate mean to reach the conclusion. Considering a loss of 20% follow-up, at least 80% patients followed the treatments [23]. An experimental group and a care group were recruited which were based on the inclusion criteria for this study (Fig. 5). Both groups were selected by regularly visiting the physiotherapy department at Social Security Hospital Gujranwala.

Fig. 5

Experimental sheet/flow sheet

Data analysis

Statistical analysis

Data were analyzed by using (SPSS Version 22.0) software. Qualitative data were presented in frequencies and percentages while mean and S. D were calculated for Quantitative data. Line chart was drawn at various times in weeks during the treatment vs pain score and UCLA score.

Repeated measure ANOVA was applied to compare average pain score as primary outcome while average UCLA score as a secondary outcome at different time points (baseline, 5th week, 11th week). The confidence level of 95% was used as well as p value ≤0.05 was considered as significant.

Results

Recruitment

The current study was started on September 2016 and last follow up was occurred on March 2018 and then trial ended. It was considered regarding the number of the participants in each group laid within the range estimated (40 each group). Data was collected at Social Security Hospital Gujranwala.

Participant flow

One hundred and twenty participants had been observed for eligibility process at the time of September 2016 till February 2018, among 30 participants had not been found eligible. The ineligible participants were excluded from the current study and was given the routine physiotherapy treatment. The reasons for ineligibility of the patients are presented in Fig. 5, out of 90 eligible participants, 10 had further excluded as they denied being part of study. The above mentioned 10 participants were also given the routine physiotherapy treatment. The rest of 80 participants divided in an experimental group and a care group. On 11th week follow-up, 12 participants left the study and 68 patients had completed the whole evaluation. The cause of withdrawal is provided in Fig. 5. The participants who did not complete treatment on 11th week measurements had been included for further analysis. The missing values of dropped out patients were included in the current analysis by using last observation carried forward (LOCF).

The experimental sheet/ flow sheet is presented through Fig. 5.

The baseline demographic profile

The baseline characteristics are presented in Table 2. Demographic profile shows that most of the patients suffering from SIS were female, who were 32 in experimental group and 26 in care group. It was also observed that mostly patients falling in type-1 Neer classification. Neer type-1 impingement was categorized by oedema as well as subacromial bursitis and supraspinatus muscle involvement. It was mostly diagnosed among those participants who were younger than 25 years of age and shown in Table 2 [3].

Table 2

Comparison of Scio-demographic data of the patients

Variable		Experimental group (N = 40)	Control group (N = 40)	P-value
Age	Years	36.38 ± 8.93	34.40 ± 9.32	0.336
Gender	Male	8 (20%)	14 (32.4)	0.133
	Female	32 (80%)	26 (65%)
Neer test	Type 1: Pain at 90°	34 (85.0%)	38 (95.0%)	0.136
	Type 2: Pain at 60°-70°	6 (15.0%)	2 (5.0%)
Affected side	Right	23 (57.5%)	23 (57.5%)	0.889
	Left	15 (37.5%)	14 (35.0%)
	Both	2 (5.0%)	3 (7.5%)

Primary outcome

The results of primary outcome were reported in Table 3. For the care group, mean scores of VAS for shoulder pain were 6.78 ± 1.14, 5.0250 ± 1.79 and 4.90 ± 1.58 at base line, 5th and 11th week respectively. For experimental group, average score of VAS was 6.95 ± 1.28, 2.15 ± 1.87 and 2.15 ± 1.55 at base line, 5th and 11th week respectively. These results indicate significant difference in score of VAS. Shoulder pain of experimental group was average improved as compared to care group at different time points (base line, 5th and 11th week).

Table 3

Comparison of mean difference (95% CI) of between and within group comparison and partial ƞ2 with P value

Outcome measures		Mean (95% CI)	Within group comparison	Mean difference (95% Cl) of between group comparison by ANOVA (Experimental vs Control)	Partial ƞ2	P-value
		Experimental group	Control group
Pain assessment	Baseline	6.95 (6.60–7.30)	6.78 (6.42–7.13)	1.82(−2.38 to-1.25)	0.34	< 0.001
	5th week	2.15 (1.60–2.71)	5.03 (4.46–5.59)
	11th week	2.15 (1.66–2.64)	4.90 (4.41–5.40)
Partial ƞ2 for time		0.79		–	–	–
Partial ƞ2 for interaction (time*group)		0.43		–	–	–
P-value for within group		< 0.001	< 0.001	–	–	–

Secondary outcome

The results of secondary outcome were reported in Table 4. For the care group, average UCLA score were 14.50 ± 2.37, 19.07 ± 4.43 and 20.10 ± 4.08 at base line, 5th and 11th week respectively. Similarly, average UCLA score for experimental group were 14.05 ± 2.59, 27.90 ± 4.13 and 28.58 ± 3.89 at base line, 5th and 11th week respectively. The UCLA score of experimental group was more improved as compared to care group at different stages.

Table 4

Comparison of mean difference (95% CI) of between and within group comparison and partial ƞ2 with P value

Outcome measures		Mean (95% CI)	Within group comparison	Mean difference (95% Cl) of between group comparison by ANOVA (Experimental vs Control)	Partial ƞ2	P-value
		Experimental group	Control group
UCLA score	Baseline	14.05 (13.27–14.83)	14.50 (13.72–15.28)	5.62 (4.32–6.92)	0.49	< 0.001
	5th week	27.90 (26.55–29.25)	19.08 (17.73–20.42)
	11th week	28.58 (27.32–29.83)	20.10 (18.84–21.36)
Partial ƞ2 for time		0.81		–	–	–
Partial ƞ2 for interaction (time*group)		0.49		–	–	–
P-value for within group		< 0.001	< 0.001	–	–	–

Outcomes and estimation

For between group comparison

Comparison of VAS between experimental and care group was assessed at 11th week. Statistically significant difference was found with P value < 0.001 and partial ƞ2 = 0.33. For the main effect of time and interaction (time*group) were ƞ2 = 0.79 and ƞ2 0.43 respectively that was shown in Table 3. Similarly, UCLA scores for functional disability in shoulder were compared between experimental and care group at 11th week that was found statistically significance difference with P value < 0.001 and Partial ƞ2 = 0.49. For the main effect of time and interaction (time*group) were ƞ2 = 0.81 and ƞ2 0.49 respectively that was shown in Table 4. Over all pain severity and shoulder disability were decreased in experimental group as compare to care group at 11th week.

Harms

Total six participants were dropped out on 11th week in experimental group, two patients were dropped out because they were not satisfied with the treatment, one patient dropped out due to worsening of the symptoms and three patients due to lack of time. Similarly in control group four patients dropped out due to dissatisfaction of the treatment given to them and two participants due to lack of time.

Discussion

The results of routine physiotherapy with and without NM during the pain

The results of the current study demonstrated the improvement of pain among the two groups with SIS at 5th and 11th week. So, it was greater betterment in the experimental group as compared to the care group. The results of a study by Pritam Deka revealed that NM has fruitful effects in mitigating the pain by restoring neurodynamics properties in upper limb [24]. Robert J Nee et al. study has found immediate relief of pain in arm with no evidence of harmful effects and future researches are recommended to check long term effects of NM on pain [25]. It was observed that the use of neuromobilization has shown beneficial effect for short period over pain [26].

The results of current study were also similar with Pritam Deka, who explored that neuromobilization was effective treatment for pain. When neurombilization combined with TENS were used, more effective results were found on cervical radiculopathy [24]. The current study determined the results to be similar to those of Matocha MA et al. who found that pain intensity decreased weekly basis as decreased in present study on 5th and 11th week but further research is needed to help clinicians in making education decision for implementing these techniques in to clinical practice [20].

In a systemic review efficacy of neuromobilization was examined, this study concluded the positive therapeutic effects of the neuromobilization [27].

The effects of routine physiotherapy with and without NM on UCLA score

The results of the current study have shown improvement in UCLA scores of experimental group as compare to care group at 5th and 11th week. Findings of this study indicated NM has positive effects to improve UCLA score.

The given findings of our study confirm this NM is effective in improving UCLA score on 5th week and 11th week. The similar results were also noted in the study of Richard F. Ellis et al. who found that shoulder pain and disability scores were significantly improved in the experimental group [27].

Neurophysiological result of spinal mobilization was earlier shown that mobilization of nervous tissue enhances peripheral blood flow, using a physiological shift toward parasympathetic domination [28, 29].

Different neuromuscular responses (like hypoalgesia, the motor neuron pool activity, afferent discharge and changes in the mobility of muscle) associated with neuromobilization indirectly indicates the spinal cord mediated effect of the NM. Neuromobilization had an quick hypoalgesic effect on C-fibre mediated pain perception, as not on A-delta fibre mediated pain perception [30].

Another reason of more improvement of function in the experimental group may be shown the restoration of mobility due to the biomechanical effects which are inter-linked with NM [30].

Limitations

There are several limitations of current study that warrant the further discussion. However, benefits of a smaller sample size were the ability to supervise the exercises program and more closely interaction with patients on a daily basis during the exercise sessions for better results. In particular, the adherence to the prescribed exercise intensity and program was excellent for both exercise treatment groups. Second, the present study (11 weeks) was also relatively reasonable in duration compared to previous training investigations [31].

Improvements in pain and functional disability score was found in the present study which indicated that 11 weeks exercise training period was a sufficient time frame to demonstrate significant training effects.

Generalizability

Clinical considerations for effective neuromobilization in clinical treatment

After recognizing the close relationship between physical capacities and life style, it is likely to be declared that implementation of NM recommended standard part of the treatment for SIS patients will decrease shoulder pain and improve function. This study shows that NM is not only feasible as a part of the treatment, but it also has a large effect size and efficient for all the times.

Patients of SIS who suffer from many challenges, so it is important to recognize that shoulder pain and functional disability score constitute an important part of overall health and daily tasks. Since shoulder impingement syndrome are known to be important key factor for daily life activities in term of pain and function. Importantly, this study, as well as neuromobilization regimes is feasible and safe to carry out within this patient group.

Trial Registration: IRCT20190121042445N1.

Conclusion

On the basis of results it is concluded that addition of NM with routine physiotherapy has greater improvement to reduce pain severity and disability in SIS patients than without NM.