Evaluation of effect of poultice (Upanaha Sweda) in low back pain (Katigraha): A randomized comparative clinical trial.

BACKGROUND: Katigraha (low back pain) is a condition where low back is afflicted either with Vata or Sama Vata (Vata involved with the toxins released due to altered digestion and metabolism) and present with symptoms such as pain with stiffness. About 60%-80% population in India suffer from this condition. Upanaha Sweda (poultice) is one of the Swedana (sudation) treatment modalities mentioned for Katigraha. As Sama (affected with toxins released from impaired digestion) and Nirama (without toxins) are two stages of Katigraha, hence, the specific type of Upanaha is required for such condition. AIMS AND
OBJECTIVE: The study was conducted to evaluate the effect of Upanaha Sweda in Katigraha (low back pain) as per the presentation of stages of Ama.
MATERIALS AND METHODS: Selected patients were categorized into two groups. In group A, patients having Samaja Katigraha, were given Panchakoladi Upanaha once a day till it became Niramaja, then shifted to Godhumadi Upanaha for 7 days and patients who had Niramaja Katigraha, Godhumadi Upanaha was used once a day for 7 days. In group B Godhumadi Upanaha was used once a day for 7 days irrespective of stages. Subjective parameters assessed were pain in the low back, stiffness, and Oswestry Disability Index (ODI) was also used. The Mann-Whitney U test and Wilcoxon signed‑rank test were used to assess results.
RESULTS: Patients who were treated considering the Sama and Nirama phases had 78.88% better results in relieving pain, stiffness, and in ODI change than the patients treated without considering the phases.
CONCLUSION: The present study showed significant results in both the groups, but patients treated as per stage wise treatment showed better effect in treating Katigraha than the patients treated with out considering the stage. Copyright:

Introduction

Vata Dosha or Sama Vata Dosha (Vata Dosha associated with Aama [the toxins released due to altered digestion and metabolism] when afflicts Kati Pradesha (low back) and produce the symptoms such as pain with stiffness, then the condition is known as Katigraha.[1]

This can be correlated with low back pain. It is the most common disorder which is characterized by dull or sharp pain and may also associated with stiffness. About 60%–80% of the general population in India suffer from low back pain during their life time[2] due to several stressful factors seen in their professional or social life and also due to wrong postural habits. It affects both men and women alike and common in the age group of 20–60 years.

Upanaha Sweda (poultice) is one of the Swedana (sudation) treatment modalities mentioned for Katigraha.[3‑7] The selection of drugs varies according to the stages of the disease. As there are two stages mentioned in Katigraha that is Samaja (with Ama) and Niramaja (without Ama),[1] specific type of Upanaha is required for each stage,[8] but generally only one type of Upanaha is being applied for both the conditions irrespective of stages, due to which its efficacy might get reduced. Panchakoladi Upanaha consists of Chavya (Piper retrofractum Vahl.), Chitraka (Plumbago zeylanica Linn.), Pippalimula (Piper longum Linn.), Pippali (Piper longum Linn.), Shunthi (Zingiber officinale Roscoe.), Yava (Hordeum vulgare Linn.) and Nirgundi (Vitex negundo Linn.) that are helpful in resolving of toxins released due to impaired digestion and Godhumadi Upanaha consists of Godhuma (Triticum sativum Linn.), Tila (Sesamum indicum Linn.), Erandamula (Ricinus communis Linn.) that are helpful in treating Vata condition. Hence, study has been carried out to evaluate the effect of Upanaha Sweda in as per the stage of Katigraha (low back pain).

Materials and Methods

The study was registered under the Clinical Trials Registry – India (CTRI/2017/04/008417) and ethical clearance had been obtained (BMK/13/PG/PK/05). Informed consent was taken before starting the trial in each subject. Forty‑one patients of Katigraha fulfilling the inclusion criteria were enrolled irrespective of sex, religion, etc. Five patients dropped out due to personal reasons and 36 patients completed the study as mentioned in Table 1. Selected patients were first openly categorized into two groups: Samaja Katigraha and Niramaja Katigraha. Then, these patients were again categorized into two groups according to the computer‑generated randomization chart. In group A (Avasthanusara [stage wise] treatment), patients presenting with Samaja Katigraha, Panchakoladi Upanaha was given once a day till the Nirama symptoms appeared and then Godhumadi Upanaha was used once a day for 7 days and the patients presenting with Niramaja Katigraha, Godhumadi Upanaha was used once a day for 7 days. Whereas in group B (Anavasthanusara [without considering stages] treatment), Godhumadi Upanaha was used for 7 days irrespective of stages.

Table 1

Distribution of registered patients of Katigraha

Group	Completed		Drop out		Total Registered
A	18	9 (Samaja)	01	03	10 (Samaja)	21
		9 (Niramaja)	02		11 (Niramaja)
B	18	9 (Samaja)	01	02	10 (Samaja)	20
		9 (Niramaja)	01		10 (Niramaja)

Diagnostic criteria

Pain at low back

Stiffness at low back

Sama symptoms, i.e., heaviness in the body, anorexia, poor digestion, excessive salivation and laziness.

Nirama symptoms, not having either of heaviness in the body, anorexia, poor digestion, excessive salivation and laziness.

Inclusion criteria

Patients presenting with classical symptoms of Katigraha such as pain and stiffness at low back.

The patients who are fit for Swedana (sudation)

The age group between 20 and 60 years of either sex.

Exclusion criteria

Low back pain resulting from osteoporotic fractures, infections, neoplasm, other mechanical derangements

Patient associated with any other systemic disorders

Patients with a history of trauma

Known case of skin allergy and open wound

Post surgical backache.

Ingredients of Upanaha 1 and Upanaha 2

Ingredients of Upanaha 1 (Panchakoladi Upanaha) and Upanaha 2 (Godhumadi Upanaha) are mentioned in Table 2.

Table 2

Ingredients of Upanaha 1 and Upanaha 2

Ingredients	Upanaha 1 (Panchakoladi Upanaha)	Quantity	Upanaha 2 (Godhumadi Upanaha)	Quantity
Medicinal powder	Chavya (P. retrofractum Vahl.) powder	10 g-15 g	Godhuma (T. sativum Linn.) powder	50 g-75 g
	Chitraka (P. zeylanica Linn.) powder	10 g-15 g	Tila (S. indicum Linn.) paste	30 g-45 g
	Pippalimula (P. longum Linn.) powder	10 g-15 g	Erandamula (R. communis Linn.) powder	100 g-125 g
	Pippali (P. longum Linn.) powder	10 g-15 g
	Shunthi (Z. officinale Roscoe.) powder	10 g-15 g
	Yava (H. vulgare Linn.) powder	50 g-75 g
	Nirgundi (V. negundo Linn.) powder	50 g-75 g
Drava Dravya (liquids)	Dhanyamla (fermented gruel)	200 ml -300 ml	Gokshira (cow milk)	200 ml -300 ml
	Saindhava Lavana (rock salt)	30 g	Saindhava Lavana (rock salt)	30 g
Oil	Tila Taila (sesame oil)	20 ml-30 ml	Tila Taila (sesame oil)	40 ml-60 ml

P. retrofractum: Piper retrofractum, P. zeylanica: Plumbago zeylanica, P. longum: Piper longum, Z. officinale: Zingiber officinale, H. vulgare: Hordeum vulgare, V. negundo: Vitex negundo, T. sativum: Triticum sativum, S. indicum: Sesamum indicum, R.communis: Ricinus communis

Preparation and application of Upanaha

Materials required for preparation of Upanaha

Tila Taila (sesame oil) 10 ml for local massage, Saindhava Lavana (rock salt) ‑ 30 g, cotton bandage ‑ 6 inches (2 pieces), Eranda (Ricinus communis Linn.) leaves ‑ (4–5), heating apparatus, pan, table spoon, bowl, thermometer and massage table.

Preparation of paste

All the medicinal powder mentioned in Table 2 were taken in a pan as per the group. Then, 200 ml Dhanyamla (fermented gruel) and 200 ml cow milk was added to Panchakoladi Upanaha and Godhumadi Upanaha respectively and mixed well. Then, 30 g Saindhava Lavana (rock salt) and Tila Taila (sesame oil) as per need were added to it for the poulitce and mixed well to make its consistency like dough.

Main procedure

The patient was instructed to lie in the prone position on the massage table. Low back was exposed and the skin sensitivity was checked for temperature or any allergy. Local massage was done with Tila Taila (sesame oil) for 5 min. The prepared paste was then pasted over the low back uniformly of about 5 mm thickness. It was covered with proper‑shaped Eranda leaves. Then, it was tied with a cotton bandage for 6 h (360 min).

Post operative procedure

After removal of Upanaha (poultice), gentle massage was done and the part was cleaned well with lukewarm water and the patient was asked to move the joint slowly.

Upanaha Dharana Kala (duration of Upanaha retention)

Panchakoladi Upanaha‑ 6 h/day till Niramaja symptoms like reduction in the stiffness and feeling of lightness at low back and activeness in the body appears parameters:

Godhumadi Upanaha‑ 6 h/day for 7 days.

Assessment criteria

Patients were assessed before and after the treatment on the basis of following parameters:

Assessment of subjective criteria

The assessment criteria for pain and stiffness are given in Tables 3 and 4, respectively.

Table 3

Assessment and grading of pain

Pain (VAS)	Scale	Grade
No pain	0 1	0
Mild, annoying pain	2 3	1
Nagging, uncomfortable, troublesome pain	4	2
Distressing, miserable pain	5 6 7	3
Intense, dreadful, horrible pain	8 9	4

Table 4

Assessment and grading of stiffness (range of motion)

Stiffness (ROM)	Grade
No stiffness	0
With up to 25% impairment in ROM of joint and patient can perform daily work without any difficulty	1
With up to 25%-50% impairment in the ROM of joint and patient can perform daily routine work with mild or moderate difficulty	2
With up to 50%-75% impairment in ROM of joint and patient can perform daily routine work with moderate or severe difficulty	3
With >75% impairment in ROM of joint and patient totally unable to perform daily routine work	4

ROM: Range of motion

Visual Analog Scale: (for assessment of pain in grade 0 to 10).

Oswestry disability index total score

Pain, stiffness and Oswestry Disability Index (ODI) changes were assessed on comparing their values after applying Mann–Whitney U test and Wilcoxon signed‑rank test.

Observations

Table 5 shows that out of 36 cases of Katigraha, 41–60 years (69.44%) of age group people were found more affected than 20–30 years (11.11%) and 31–40 years (19.44%); Table 6 shows that males (52.78%) were found more affected with low backache than females (47.22%); Table 7 shows that farmers and labourers (27.78%) and homemakers (33.33) were more prone to low backache than private job workers (16.67%), teachers (13.88%), policeman (2.78%) and tailors (5.56%); Table 8 shows that prolong standing posture (38.89) persons are more prone to low backache than prolong sitting postures (30.56%) and continuous travellers (8.33%).

Table 5

Age wise distribution of patients

Age (Years)	Avasthanusara Group		Anavasthanusara Group		Total
	No.	%	No.	%	No.	%
20-30	03	16.16	01	5.56	04	11.11
31-40	04	22.22	03	16.67	07	19.44
41-60	11	61.11	14	77.77	25	69.44

Table 6

Distribution of patients according to gender

Sex	Avasthanusara Group		Anavasthanusara Group		Total
	No.	%	No.	%	No.	%
Male	09	50	10	55.56	19	52.78
Female	09	50	08	44.44	17	47.22

Table 7

Distribution of patients on the basis of occupation

Occupation	Avasthanusara Group		Anavasthanusara Group		Total
	No.	%	No.	%	No.	%
Farmer/Labor	06	33.33	04	22.22	10	27.78
Teacher	03	16.67	02	11.11	05	13.88
Private job	04	22.22	02	11.11	06	16.67
House wife	05	27.77	07	38.88	12	33.33
Policeman	00	00	01	5.55	01	2.78
Tailor	00	00	02	11.11	02	5.56

Table 8

Distribution of patients on the basis of postural details

Postural Details	Avasthanusara Group		Anavasthanusara Group		Total
	No.	%	No.	%	No.	%
Prolonged sitting	06	33.33	05	27.78	11	30.56
Prolong standing	07	38.89	07	38.89	14	38.89
Continuous travel	01	5.56	02	11.11	03	8.33
Not related	04	22.22	04	22.22	08	22.22

Results

Results of the treatment in both the groups are mentioned in Tables 9 and 10.

Table 9

Results of the treatment on parameters of low back pain

Parameter	Group	Mean±SD		Improvement (%)	Z	Significance/P
		BT	AT
VAS	Avasthanusara treatment	5.11±0.74	2.89±0.99	43.33	10.00	<0.0001
	Anavasthanusara treatment	4.89±1.24	3.56±1.3	27.2	5.49	<0.0001
	Between the groups				2.7	0.0107
Stiffness	Avasthanusara treatment	1.83±0.6	1.17±0.76	36.07	4.76	0.0002
	Anavasthanusara treatment	1.78±0.71	1.5±0.76	15.73	2.56	0.0204
	Between the groups				2.19	0.0351
ODI	Avasthanusara treatment	47.11±6.41	29.56±9.04	37.25	9.47	<0.0001
	Anavasthanusara treatment	45.44±10.87	37.06±10.9	18.44	7.69	<0.0001
	Between the groups				4.26	0.0002

SD: Standard deviation, VAS: Visual analog scale, ODI: Oswestry Disability Index, BT: Before treatment, AT: After treatment

Table 10

Results of the treatment in Samaja Katigraha

Parameter	Group	Mean±SD		Improvement (%)	Z	Significance/P
		BT	AT
VAS	Avasthanusara treatment	5.22+0.63	2.56+0.83	50.96	11.31	<0.0001
	Anavasthanusara treatment	4.67+1.25	3.67+1.33	21.41	2.68	0.0278
	Between the groups				3.78	0.0016
Stiffness	Avasthanusara treatment	2+0.47	0.89+0.57	55.5	10.00	<0.0001
	Anavasthanusara treatment	2+0.67	1.78+0.63	11	1.51	0.1690/ns
	Between the groups				4.82	0.0002
ODI	Avasthanusara treatment	48.11+5.74	28.67+7.92	40.40	8.58	<0.0001
	Anavasthanusara treatment	46.78+11.45	39.22+12.16	16.16	3.73	0.0058
	Between the groups				3.90	0.0013

SD: Standard deviation, VAS: Visual analog scale, ODI: Oswestry Disability Index, BT: Before treatment, AT: After treatment

Table 9 shows that 18 patients of Katigraha when treated according to Avastha (stages) showed 43.33% effect with P < 0.0001 in relieving pain, 36.07% effect with P = 0.0002 in reducing stiffness, and 37.25% effect with P < 0.0001 in improving ODI index and another 18 patients of Katigraha when treated without assessing the Avastha (stages) showed 27.20% effect with P < 0.0001 in relieving pain, 15.73% effect with P = 0.0204 in reducing stiffness, and 18.44% effect with P < 0.0001 in improving of ODI index.

Table 9 also shows that there was a significant difference between the two groups with P = 0.0107 in relieving pain, with P = 0.0351 in reducing stiffness and with P = 0.0002 in improving of ODI index.

Table 10 shows that 9 patients of Samaja Katigraha when treated according to Avastha (stages) had 50.96% effect with P < 0.0001 in relieving pain, 55.5% effect with P < 0.0001 in reducing stiffness, and 40.40% effect with P < 0.0001 in improving ODI index and another 9 patients of Samaja Katigraha when treated without assessing the Avastha (stages) showed 21.41% effect with P = 0.0278 in relieving pain, 11% effect with P = 0.1690 in reducing stiffness, and 16.16% effect with P = 0.0058 in improving of ODI index.

Table 10 also shows that there was a significant difference between the results in Samaja Katigraha of the two groups with P = 0.0016 in relieving pain, with P = 0.0002 in reducing stiffness and with P = 0.0013 in improving of ODI index.

Discussion

Of 36 cases of Katigraha males, prolong standing posture, moderate working lifestyle, labourers, and homemakers were affected more with Katigraha might be because they have to do more laborious work and prolong standing posture exerts pressure over low back and provides favorable condition for lodging (Sthana Samshraya) of already vitiated Vata Dosha. Age‑wise distribution showed that 40–60 years of age group were found more prone to Katigraha because degenerative changes starts in this age group that leads to Vata vitiated disorders.

The effect of Avasthanusara treatment is better than Anavasthanusara treatment might be because:

Pain is the symptom of Vata Dosha. Drugs used in Panchakoladi Upanaha were having Ushna (hot) and Tikshna (sharp) properties, so it did Doshavilayana (liquefaction of Dosha) and Srotoshodhana (purification of channels) which helped in relieving Margavarana (obstruction in channels) of Vata Dosha, followed by Godhumadi Upanaha that is having Snigdha (unctuous) property along with Ushna property, that helped in pacifying Vata Dosha, thus helped in relieving pain

Stiffness is either due to Sheeta (cold) – Ruksha (dry) properties of Vata or Sheeta ‑ Snigdha properties of Ama. Drugs used for Panchakoladi Upanaha are having Ushna, Ruksha and Tikshna properties which helped in pacifying Sheeta ‑ Snigdha properties of Ama efficiently

Avasthanusara treatment had a significant effect on reducing pain and stiffness both, thus it helped in improving quality of life of the patients. Although Anavasthanusara treatment group provided effect on reducing pain and stiffness, but as it is having Amaja stage of patients and were treated without considering stages, it was not effective statistically.

Probable mode of action of Upanaha

The lipoidal bond is suitable for penetration of drug molecule through stratum corneum.[9] On this basis, it can be assumed that in Upanaha, oil helps in the formation of lipoidal bond with other drugs thus helps in the penetration of drug molecules. Upanaha is a type of Swedana, so it induces hyperthermia which improves local blood and lymphatic circulation and thereby improving local tissue metabolism.[10] It reduces inflammation by modifying secretion of various inflammatory mediators, relaxes local musculature by physical effect of heat, increases the rate of transdermal drug delivery and thereby reduces pain.[11]

The drugs used for Panchakoladi Upanaha are having alkaloids such as piperine[12] (in Pippali), terpenoids[13] (in Chavya), gingerol[14] (in Shunthi), tannins,[15] and saponins[16] (in Yava), thus they inhibit prostaglandins (acting as a vasodilators and cause inflammation[17]), which, in turn, may reduce the inflammation.

Drugs used in Panchakoladi Upanaha are Ushna, Tikshna in nature and due to its counter irritant effect, helped in relieving pain.

Conclusion

Patients of low back pain treated with Avasthanusara (stage wise treatment) had better effect in relieving pain, stiffness and in Oswestry Disability Index (ODI) change than the patients treated with Anavasthanusara Upanaha Sweda without stage wise treatment. Also, patients of Samaja Katigraha treated with Panchakoladi Upanaha had better effect in relieving pain, stiffness and in ODI change than the patients of Samaja Katigraha treated with Godhumadi Upanaha. Thus, it can be concluded that Panchakoladi Upanaha was effective in relieving Samaja stage of Katigraha and Avasthanusara treatment is more effective in the management of Katigraha than that of Anavasthanusara treatment.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.