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

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ClinicalTrials.gov Identifier: NCT03711409
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Yi-Fen Shih, National Yang Ming University

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.

Condition or disease Intervention/treatment Phase
Frozen Shoulder Shoulder Adhesive Capsulitis Other: Soft tissue biased manual therapy group Other: Conventional physical therapy group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects are divided into soft tissue biased manual therapy group and conventional physical therapy group by two different hospitals
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Soft Tissue Biased Manual Therapy and Conventional Physical Therapy on Shoulder Kinematics, Muscle Performance, Functional Impairment & Pain in Patients With Frozen Shoulder
Actual Study Start Date : December 25, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Soft tissue biased manual therapy group
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
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.

Experimental: Conventional physical therapy group
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
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Range of motion of shoulder joint (Goniometer) [ Time Frame: Baseline, 3-week intervention and 6-week intervention ]
    Shoulder range of motion in degree of flexion, abduction, internal rotation and external rotation

  2. Mechanical stress relaxation time (ms) of shoulder muscles [ Time Frame: Baseline, 3-week intervention and 6-week intervention ]
    We use Myotometer to measure mechanical stress relaxation time (ms) of pectoralis major, infraspinatus, teres complex and upper trapezius

  3. Creep of shoulder muscles [ Time Frame: Baseline, 3-week intervention and 6-week intervention ]
    We use Myotometer to measure creep of pectoralis major, infraspinatus, teres complex and upper trapezius

  4. Oscillation frequency (Hz) of shoulder muscles [ Time Frame: Baseline, 3-week intervention and 6-week intervention ]
    We use Myotometer to measure oscillation frequency (Hz) of pectoralis major, infraspinatus, teres complex and upper trapezius

  5. Dynamic stiffness (N/m) of shoulder muscles [ Time Frame: Baseline, 3-week intervention and 6-week intervention ]
    We use Myotometer to measure dynamic stiffness (N/m) of pectoralis major, infraspinatus, teres complex and upper trapezius

  6. Muscle strength of shoulder muscles (Hand-held Dyanometer) [ Time Frame: Baseline, 3-week intervention and 6-week intervention ]
    Shoulder muscle strength in Kgw of lower trapezius, internal rotators and external rotators

  7. Scapula dyskinesia [ Time Frame: Baseline, 3-week intervention and 6-week intervention ]
    Use modified lateral scapular slide test to measure during arms by sides, hands on hips and scaption movement

  8. Shoulder disability [ Time Frame: Baseline, 3-week intervention and 6-week intervention ]
    Use Flexilevel Scale of Shoulder Function (Flex-SF) questionnaire Chinese version to measure the disability level of frozen shoulder patients. Flex-SF uses 4-point Likert Scale to measure the disability level. Subjects need to answer a routing question and subgroup them into three different difficulty level. The scores range from 1 to 48 (1= most disable, 48= least disable).

  9. Shoulder pain [ Time Frame: Baseline, 3-week intervention and 6-week intervention ]
    Use visual analogue scale to measure shoulder pain of frozen shoulder patients. We will provide subjects a 10-cm scale for them to point the intensity of their pain (on a 10-cm scale, 0 cm = no pain, 10 cm = the most severe pain).

  10. Scapula motor control (muscle activation percentage) [ Time Frame: Baseline and after 6-week intervention ]
    Change from baseline of scapular muscles' activation in percentage during scaption, hand to neck and hand to back task to after 6-week intervention



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711409


Contacts
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Contact: Shih Yi-Fen, PhD +886-2-28267340 yfshih@ym.edu.tw
Contact: Tang Chun-Kai, BS +886-2-28210271 cktang@gm.ym.edu.tw

Locations
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Taiwan
National Yang Ming University Recruiting
Taipei, Taiwan, 11221
Contact: Yifen Shih, PHD    +886-2-2826-7340    yfshih@ym.edu.tw   
Sponsors and Collaborators
National Yang Ming University
Investigators
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Study Director: Shih Yi-Fen, PhD Department of Physical Therapy and Assistive Technology, National Yang-Ming University

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Responsible Party: Yi-Fen Shih, Professor, Department of Physical Therapy and Assistive Technology, National Yang-Ming University, National Yang Ming University
ClinicalTrials.gov Identifier: NCT03711409     History of Changes
Other Study ID Numbers: TCHIRB-10705119-E
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yi-Fen Shih, National Yang Ming University:
Frozen Shoulder
Manual therapy
Soft tissue mobilization

Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases