Comparison of Soft Tissue Biased Manual Therapy and Conventional Physical Therapy in Patients With Frozen Shoulder

NCT03711409 | Completed

• 1 other identifier: TCHIRB-10705119-E
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Adhesive capsulitis, also known as frozen shoulder (FS), is a condition characterized by the functional restriction of both active and passive shoulder motion with unremarkable glenohumeral joint radiographs findings. Shoulder pain almost exists during the whole course of frozen shoulder. Pain induces muscle spasm and causes pain-spasm-pain cycle resulting in limited range of motion, changed muscle recruitment pattern and finally influences neuromuscular control. Commonly used conservative interventions for FS patients include joint mobilization, corticosteroid injection, exercise, modality and soft tissue mobilization. Despite joint mobilization is the most commonly used manual therapy in patients with FS, the evidence level is weak and the efficacy is not superior to other conservative treatments. Soft tissue mobilization is widely used in lots of musculoskeletal conditions. The effects of soft tissue mobilization include breaking the adhesion tissue and improving range of motion, muscle strength and motor control. However, few studies have investigated the effect of soft tissue mobilization in patients with frozen shoulder. Therefore, the purpose of this study is to investigate and compare the effect of soft tissue biased manual therapy and conventional physical therapy in patients with primary FS.

Conditions

Frozen Shoulder; Shoulder Adhesive Capsulitis

Keywords

Frozen Shoulder; Manual therapy; Soft tissue mobilization

Outcome Measures

Primary Outcomes (1)

• Scapulo-humeral rhythm (scapular kinematics) during functional movements

  Change from baseline of scapular kinematics to after 6 week intervention during scaption task, hand to neck task and hand to back task

  Baseline and after 6-week intervention

Secondary Outcomes (10)

• Range of motion of shoulder joint (Goniometer)

  Baseline, 3-week intervention and 6-week intervention

• Mechanical stress relaxation time (ms) of shoulder muscles

  Baseline, 3-week intervention and 6-week intervention

• Creep of shoulder muscles

  Baseline, 3-week intervention and 6-week intervention

• Oscillation frequency (Hz) of shoulder muscles

  Baseline, 3-week intervention and 6-week intervention

• Dynamic stiffness (N/m) of shoulder muscles

  Baseline, 3-week intervention and 6-week intervention

Study Arms (2)

Soft tissue biased manual therapy group

EXPERIMENTAL

It includes hot pack and muscle release technique of the muscles around the shoulder. The patient receives treatment 45 minutes per times and 2 times per week for 6 weeks.

Other: Soft tissue biased manual therapy group

Conventional physical therapy group

EXPERIMENTAL

It includes modality (electrotherapy, ultrasound and low-level laser therapy) and GH joint mobilization. The patient receives treatment 45 minutes per times and 2 times per week for 6 weeks.

Other: Conventional physical therapy group

Interventions

Soft tissue biased manual therapy group OTHER

It includes hot pack and muscle release technique of pectoralis major, pectoralis minor, teres major, teres minor, infraspinatus and posterior deltoid muscles. Subjects are supine on the bed. The muscle release technique is applied at the end available range and the acceptable intensity. The time of muscle release intervention is about 30 min and hot-pack about 15 min.

Soft tissue biased manual therapy group

Conventional physical therapy group OTHER

It includes modality (electrotherapy, ultrasound and low-level laser therapy) and GH joint mobilization. GH joint mobilization includes anterior to posterior glide, caudal glide and distraction. The intensity of joint mobilization is grade III to IV. The time of joint mobilization is about 30 min and hot-pack for 15 min.

Conventional physical therapy group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary adhesive capsulitis diagnosed by orthopaedic surgeon or physiatrist
• Reduction in range of motion in more than two planes
• \< 30 degrees of the external rotation range of motion during shoulder abduct to 90 degree
• No radiologic abnormality
• Onset time more than three months
• No night pain and resting pain

You may not qualify if:

• History of stroke, diabetes mellitus, rheumatoid arthritis, rotator cuff tear, shoulder osteoarthritis, surgical stabilization/surgery of the shoulder, osteoporosis, or malignancies in the shoulder region

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming University

Taipei, 11221, Taiwan

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Shih Yi-Fen, PhD

  Department of Physical Therapy and Assistive Technology, National Yang-Ming University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Physical Therapy and Assistive Technology, National Yang-Ming University

Model Details: Subjects are divided into soft tissue biased manual therapy group and conventional physical therapy group by two different hospitals

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: October 18, 2018
• Study Start: December 25, 2018
• Primary Completion: January 31, 2020
• Study Completion: February 28, 2020
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

TW (1)