Postural Decoding for Post-Stroke Shoulder Pain: A RCT.

NCT06763796 | Active Not Recruiting DMC

• 2 other identifiers: KY-2024-902024JD056
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary Purpose of the Study: This clinical trial aims to determine whether Postural Decryption Technique can effectively treat hemiplegic shoulder pain (HSP) in patients recovering from stroke. It also seeks to assess the safety of this technique. The study will compare the effectiveness of the Postural Decryption Technique with traditional massage therapy to find out which method provides better pain relief and improves shoulder function. Key Research Questions:

1. 1.Can the Postural Decryption Technique reduce shoulder pain and improve range of motion in HSP patients?
2. 2.Is the Postural Decryption Technique more effective than traditional massage therapy?
3. 3.Is the Postural Decryption Technique safe, and are there any side effects or discomfort during treatment?
4. 4.Researchers will recruit 48 participants with HSP and randomly divide them into two groups:
5. 5.Pain Assessment: Pain levels will be measured using the Visual Analog Scale (VAS).
6. 6.Range of Motion (ROM): Tools will be used to measure the angles of shoulder movement.
7. 7.Postural Assessment: The position of the scapula and spine will be measured to evaluate postural alignment improvements.
8. 8.Daily Activity Ability: Progress in daily tasks will be recorded using the Barthel Index questionnaire.

Conditions

Stroke; Sequelae

Keywords

Hemiplegic Shoulder Pain；Postural Decryption Technique；Musculoskeletal Ultrasound Assessment；Postural Assessment； Randomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

• VAS（Visual Analog Scale）

  In the Visual Analog Scale (VAS) scoring system, patients are presented with an unmarked line that is 10 centimeters long. Patients indicate their level of pain by marking a point along the line. The position of the mark is measured using a ruler, yielding a corresponding numerical value. The VAS score ranges from 0 to 10, where 0 represents no pain and 10 represents the most severe pain. Higher scores indicate greater pain intensity.

  The assessment time points are before treatment, 2 weeks after treatment, and 4 weeks after treatment.

• Range of motion，ROM

  A goniometer is used to measure the flexion, abduction, and extension range of motion (ROM) of the shoulder joint in both groups of patients.

  The assessment time points are before treatment, 2 weeks after treatment, and 4 weeks after treatment.

• The absolute value of the vertical distance difference between the medial superior angle of the scapula on the affected side and the spinous process of the second thoracic vertebra (T2).

  The patient sits comfortably with arms relaxed at their sides. The medial superior angle of the scapula is marked as Point 1, and the spinous process of the second thoracic vertebra (T2) is marked as Point 2. A ruler or measuring tape is used to measure the vertical distance between these two points. The absolute value of the distance difference before and after treatment is recorded to evaluate the effectiveness of the intervention, with a smaller difference indicating improved scapular alignment and postural symmetry.

  The assessment time points are before treatment, 2 weeks after treatment, and 4 weeks after treatment.

Secondary Outcomes (2)

• Barthel Index

  The assessment time points are before treatment, 2 weeks after treatment, and 4 weeks after treatment.

• musculoskeletal ultrasound

  The assessment time points are before treatment, 2 weeks after treatment, and 4 weeks after treatment.

Study Arms (2)

Intervention Group (Postural Decryption Technique Group)

ACTIVE COMPARATOR

Assessment: PDT begins with visual inspection and palpation to assess neutral alignment of the trunk, spine, and shoulder complex. Evaluations proceed distal to proximal through coronal, sagittal, and transverse planes, focusing on joint symmetry. Treatment: The 4R Technique includes: 1. Reposition - Correct joint alignment. 2. Restore - Release soft tissue adhesions. 3. Reinforce - Strengthen stabilizing muscles. 4. Retrain - Improve movement patterns. Key Steps: 1. Lumbar and Thoracic Adjustments: Manual traction, side-bending, and mobilizations. 2. Scapular Realignment: Mobilization and muscle stretching. 3. Joint Mobilization: Multi-directional gliding within pain-free ranges. 4. Trigger Point Release: Pressure therapy for 5-10 seconds to relieve pain. Treatment Plan: 4 weeks, 5 sessions per week, 40 minutes per session. Targets pain relief, range of motion, and postural correction in hemiplegic shoulder pain (HSP) patients.

Other: Postural Decryption Technique

Control Group: Traditional Massage Group

ACTIVE COMPARATOR

Treatment: The control group receives traditional massage therapy focused on: 1. Soft Tissue Relaxation - Kneading, pressing, and rolling to reduce muscle tension. 2. Joint Mobilization - Passive movements to improve range of motion (ROM). Pain Relief Techniques - Acupressure and trigger point therapy to ease pain and spasms. Treatment Plan: 4 weeks, 5 sessions per week, 40 minutes per session. Targets pain relief, ROM improvement, and muscle relaxation in hemiplegic shoulder pain (HSP) patients.

Other: Traditional Chinese Medicine (TCM) Massage Therapy

Interventions

Postural Decryption Technique OTHER

Assessment: PDT begins with visual inspection and palpation to check postural alignment and identify joint or muscle imbalances. Evaluations proceed distal to proximal, examining the spine and shoulder complex in coronal, sagittal, and transverse planes to assess symmetry and neutral positioning. Treatment Process: PDT applies the 4R Technique: 1. Reposition - Correct joint alignment. 2. Restore - Release muscle tension and adhesions. 3. Reinforce - Strengthen stabilizing muscles. 4. Retrain - Improve movement patterns and posture. Key Techniques: 1. Spinal and Shoulder Adjustments: Manual traction, mobilizations, and stretches. 2. Joint Mobilization: Multi-directional gliding within pain-free ranges. 3. Trigger Point Therapy: 5-10 seconds of pressure to relieve localized pain. 4. Proprioception Training: Balance challenges to improve stability and control.

Intervention Group (Postural Decryption Technique Group)

Traditional Chinese Medicine (TCM) Massage Therapy OTHER

Definition: A manual therapy based on Traditional Chinese Medicine (TCM) principles, using techniques like kneading, pressing, rolling, and stretching to relieve pain, improve circulation, and enhance mobility. Key Features: 1. Techniques: Soft tissue manipulation, joint mobilization, and acupressure. 2. Focus: Pain relief, joint function recovery, and muscle relaxation. Treatment Plan: 4 weeks, 5 sessions per week, 40 minutes per session.

Control Group: Traditional Massage Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets the diagnostic criteria for stroke.
• Presence of stroke-related lesions confirmed by cranial CT or MRI.
• Hemiplegic shoulder pain and motor dysfunction on the affected side.
• Shoulder pain occurring after paralysis, with a VAS score ≥ 5.
• ≥ 18 years.
• First-ever stroke, presenting with unilateral limb paralysis, and classified
• between Stages II-V based on Brunnstrom motor function recovery stages.
• No severe cognitive impairment, with normal cognitive function assessment. Signed informed consent form.

You may not qualify if:

• Subarachnoid hemorrhage.
• History of two or more strokes.
• Shoulder subluxation in the flaccid stage.
• Disease progression with new infarction or hemorrhagic lesions.
• Severe cardiopulmonary diseases, including acute myocardial infarction, unstable angina, myocardial ischemia detected on resting ECG, severe arrhythmias, aortic stenosis, acute pericarditis, or malignant hypertension.
• Shoulder pain caused by cervical spondylosis, periarthritis, sports injuries, gallbladder disease, thalamic lesions, or myocardial infarction.
• Severe psychological or cognitive impairments that prevent cooperation with treatment.

Sponsors & Collaborators

• Shenzhen Baoan District Fuyong People's Hospital: lead

Study Sites (1)

Department of Rehabilitation, Fuyong People's Hospital of Bao'an District, Shenzhen

Shenzhen, Guangdong, 518103, China

Location

Related Publications (1)

• Song C, Lei B, Li Z, Li H, Tian S, Feng N. Discovery of Posture Secret manual therapy for post-stroke shoulder pain: study protocol for a randomized controlled trial. Front Neurol. 2025 Sep 12;16:1594560. doi: 10.3389/fneur.2025.1594560. eCollection 2025.

  PMID: 41018195 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Medicine, Chinese Traditional; Massage

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics; Therapy, Soft Tissue; Musculoskeletal Manipulations; Physical Therapy Modalities; Rehabilitation

Study Officials

• Bo Lei

  Fuyong People's Hospital of Bao'an District, Shenzhen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 8, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)