OBJECTIVE: The aim of this study was to assess the methods to conduct a substantive clinical trial to evaluate the effects of accessory joint mobilization (AJM) vs neural mobilization (NM) techniques for shoulder motion restriction after breast cancer surgery. METHODS: This pilot study was a prospective randomized and double-blind clinical trial in which 18 women who underwent unilateral breast cancer surgery and axillary lymph node dissection participated. The study was conducted at the Women's Health Research Group at the Physical Therapy Department of Alcalá University, Madrid, Spain. The intervention was AJM vs NM, with a 6-month follow-up. Primary outcomes included recruitment, adherence to treatment and retention rates, assessment procedures, and implementation of the 2 manual therapy techniques. Secondary outcomes included range of motion, sensory disturbance, pain, and upper limb functionality. RESULTS: All participants accepted to be randomly assigned to study groups. One hundred percent retention was attained with all participants attending the 3-month and 6-month assessments. Adherence with treatment attendance was excellent. At 6-month follow-up, flexion range of motion had a mean change of 38.4° (±28.9) (P = .002) in the AJM group and a mean change of 36.8° (±21.8) (P = .002) in the NM group. Abduction range of motion had a median change of 52.4° (±43.6) (P = .004) in AJM group and a median change of 44° (±17.5) (P = .012). CONCLUSIONS: These preliminary results of the effects of AJM and NM techniques in breast cancer survivors indicate that a full clinical trial will be worthwhile. The research methods tested and the modifications proposed within this pilot study offer a suitable foundation to conduct a substantive clinical trial.
RCT Entities:
OBJECTIVE: The aim of this study was to assess the methods to conduct a substantive clinical trial to evaluate the effects of accessory joint mobilization (AJM) vs neural mobilization (NM) techniques for shoulder motion restriction after breast cancer surgery. METHODS: This pilot study was a prospective randomized and double-blind clinical trial in which 18 women who underwent unilateral breast cancer surgery and axillary lymph node dissection participated. The study was conducted at the Women's Health Research Group at the Physical Therapy Department of Alcalá University, Madrid, Spain. The intervention was AJM vs NM, with a 6-month follow-up. Primary outcomes included recruitment, adherence to treatment and retention rates, assessment procedures, and implementation of the 2 manual therapy techniques. Secondary outcomes included range of motion, sensory disturbance, pain, and upper limb functionality. RESULTS: All participants accepted to be randomly assigned to study groups. One hundred percent retention was attained with all participants attending the 3-month and 6-month assessments. Adherence with treatment attendance was excellent. At 6-month follow-up, flexion range of motion had a mean change of 38.4° (±28.9) (P = .002) in the AJM group and a mean change of 36.8° (±21.8) (P = .002) in the NM group. Abduction range of motion had a median change of 52.4° (±43.6) (P = .004) in AJM group and a median change of 44° (±17.5) (P = .012). CONCLUSIONS: These preliminary results of the effects of AJM and NM techniques in breast cancer survivors indicate that a full clinical trial will be worthwhile. The research methods tested and the modifications proposed within this pilot study offer a suitable foundation to conduct a substantive clinical trial.
Entities:
Keywords:
Accessory Joint Mobilization; Breast Cancer; Joint Range of Motion; Neural Mobilization; Physical Therapy; Shoulder
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