Skip to main content
Clinical Trials/NCT03711409
NCT03711409CompletedNot Applicable

Comparison of Soft Tissue Biased Manual Therapy and Conventional Physical Therapy on Shoulder Kinematics, Muscle Performance, Functional Impairment & Pain in Patients With Frozen Shoulder

National Yang Ming Chiao Tung University1 site in 1 country34 target enrollmentStarted: December 25, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
34
Locations
1
Primary Endpoint
Scapulo-humeral rhythm (scapular kinematics) during functional movements

Study Overview

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.

Detailed Description

Adhesive capsulitis, also known as frozen shoulder (FS), is a condition characterized by a functional restriction of both active and passive shoulder motion with unremarkable glenohumeral joint radiographs findings. Frozen shoulder is divided into primary and secondary type. The mechanism of primary FS is still unknown and the secondary FS may accompany with shoulder injuries. The incidence of primary FS is 2 to 5.8% and the risk factors are diabetes and thyroid disease.

The course of FS is divided into four consecutive stages which are inflammation, painful, frozen and thawing phase. Shoulder pain almost exists during the whole course of frozen shoulder. The pain and discomfort of FS patients are frequently localized to the deltoid insertion and coracoid process. 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 treatment s. 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. Only one study used one-time muscle release to FS patients and investigate improvement in shoulder biomechanics, muscle strength and ROM. Therefore, the purpose of this study is to investigate and compare the effect of soft tissue biased manual therapy and conventional physical therapy for six weeks in patients with primary FS.

The study design is a pretest-posttest control group design. The investigators plan to recruit 70 patients with primary frozen shoulder and divide them into a soft tissue biased manual therapy group and a conventional physical therapy group. The sample size is determined by the previous study. It is based on a significance level of 0.05, and a power of 0.80. The outcome measures in this study include scapula kinematics, scapula position, the range of motion, muscle tone, muscle strength, pain and functional impairment.

LIBERTY™ electromagnetic tracking system (Polhemus, Colchester, VT, USA) was used to collect three-dimensional kinematic (3D) data during scaption, hand to neck and hand to back tasks at a sampling rate of 120 Hz, and the software Motion Monitor® (Innovative Sport Training, Inc., Chicago. IL. USA) was used to analyze the data. The main measurements of shoulder kinematics include scapular upward/downward rotation, internal/external rotation, and anterior/posterior tilt. A stylus was used to digitize the bony landmarks for defining the anatomical coordinate system. The methods for this measure have been described previously.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

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.

Intervention: Soft tissue biased manual therapy group (Other)

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.

Intervention: Conventional physical therapy group (Other)

Outcomes

Primary Outcomes

Scapulo-humeral rhythm (scapular kinematics) during functional movements

Time Frame: Baseline and after 6-week intervention

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

Secondary Outcomes

  • Range of motion of shoulder joint (Goniometer)(Baseline, 3-week intervention and 6-week intervention)
  • Dynamic stiffness (N/m) of shoulder muscles(Baseline, 3-week intervention and 6-week intervention)
  • Creep of shoulder muscles(Baseline, 3-week intervention and 6-week intervention)
  • Shoulder disability(Baseline, 3-week intervention and 6-week intervention)
  • Mechanical stress relaxation time (ms) of shoulder muscles(Baseline, 3-week intervention and 6-week intervention)
  • Muscle strength of shoulder muscles (Hand-held Dyanometer)(Baseline, 3-week intervention and 6-week intervention)
  • Scapula dyskinesia(Baseline, 3-week intervention and 6-week intervention)
  • Shoulder pain(Baseline, 3-week intervention and 6-week intervention)
  • Scapula motor control (muscle activation percentage)(Baseline and after 6-week intervention)
  • Oscillation frequency (Hz) of shoulder muscles(Baseline, 3-week intervention and 6-week intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yi-Fen Shih

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

National Yang Ming Chiao Tung University

Study Sites (1)

Loading locations...

Similar Trials