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Frozen ShoulderNCT03711409

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

A study testing Soft tissue biased manual therapy group and Conventional physical therapy group in people with Frozen Shoulder and Shoulder Adhesive Capsulitis, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Frozen Shoulder, Shoulder Adhesive Capsulitis
What is being tested?
Soft tissue biased manual therapy group and Conventional physical therapy group
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteTaiwan
Study dates
25 Dec 2018to 28 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Yang Ming University

    Taipei, 11221

Other trials in Taiwan

About this study

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

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.

Read the 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.

For collecting muscle activation data, the investigators used surface electromyography (sEMG, TeleMyo 2400 G2 Telemetry; Noraxon USA, Inc., USA) to collect scapular muscles' activation during those tasks. The investigators will measure the muscle activities of the pectoralis major, upper trapezius, infraspinatus, teres major and lower trapezius. The electrodes will be placed according to previous studies and be positioned in parallel to the direction of the muscle fibers.

The range of motion of shoulder flexion, abduction, external rotation and internal rotation will be measured by plastic universal goniometer according to Norkin's methods. The muscle strength of lower trapezius, external rotators and internal rotators are measured by the hand-held dynamometer. The scapula positions are measured by modified scapular sliding test with calliper during arms by sides, hands on the hips and scaption 90 degrees. The muscle tone of pectoralis major, upper trapezius, infraspinatus and teres complex will be measured by hand-held myotonometer (Myoton-Pro, Myoton AS, Tallinn, Estonia) in shoulder resting position according to previous studies. The functional impairments are measured by Flexilevel Scale of Shoulder Function questionnaire. The pain level is measured by the visual analogue scale.

Participants in the soft tissue biased manual therapy group will receive heat and muscle release for six weeks and participants in conventional physical therapy group will receive modalities and joint mobilization for six weeks. The measurement will be obtained at baseline, 3 weeks, and after the intervention. Repeated measures ANOVA will be used for data analysis. The level of significance sets at α=0.05.

Being tested
Soft tissue biased manual therapy group, Conventional physical therapy group
Keywords
Frozen Shoulder, Manual therapy, Soft tissue mobilization
Medical subject headings
Bursitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Soft tissue biased manual therapy groupOther

    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.

  • Conventional physical therapy groupOther

    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.

Study groups in NCT03711409
Study groupRoleWhat they receive
Soft tissue biased manual therapy groupExperimentalIt 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.
Receives: Other: Soft tissue biased manual therapy group
Conventional physical therapy groupExperimentalIt 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.
Receives: Other: Conventional physical therapy group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and after 6-week intervention

Secondary outcomes (10)
  1. Range of motion of shoulder joint (Goniometer)

    Shoulder range of motion in degree of flexion, abduction, internal rotation and external rotation

    Measured: Baseline, 3-week intervention and 6-week intervention

  2. Mechanical stress relaxation time (ms) of shoulder muscles

    We use Myotometer to measure mechanical stress relaxation time (ms) of pectoralis major, infraspinatus, teres complex and upper trapezius

    Measured: Baseline, 3-week intervention and 6-week intervention

  3. Creep of shoulder muscles

    We use Myotometer to measure creep of pectoralis major, infraspinatus, teres complex and upper trapezius

    Measured: Baseline, 3-week intervention and 6-week intervention

  4. Oscillation frequency (Hz) of shoulder muscles

    We use Myotometer to measure oscillation frequency (Hz) of pectoralis major, infraspinatus, teres complex and upper trapezius

    Measured: Baseline, 3-week intervention and 6-week intervention

  5. Dynamic stiffness (N/m) of shoulder muscles

    We use Myotometer to measure dynamic stiffness (N/m) of pectoralis major, infraspinatus, teres complex and upper trapezius

    Measured: Baseline, 3-week intervention and 6-week intervention

  6. Muscle strength of shoulder muscles (Hand-held Dyanometer)

    Shoulder muscle strength in Kgw of lower trapezius, internal rotators and external rotators

    Measured: Baseline, 3-week intervention and 6-week intervention

  7. Scapula dyskinesia

    Use modified lateral scapular slide test to measure during arms by sides, hands on hips and scaption movement

    Measured: Baseline, 3-week intervention and 6-week intervention

  8. Shoulder disability

    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).

    Measured: Baseline, 3-week intervention and 6-week intervention

  9. Shoulder pain

    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).

    Measured: Baseline, 3-week intervention and 6-week intervention

  10. Scapula motor control (muscle activation percentage)

    Change from baseline of scapular muscles' activation in percentage during scaption, hand to neck and hand to back task to after 6-week intervention

    Measured: Baseline and after 6-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2018
  2. Study start25 Dec 2018
  3. Primary completion31 Jan 2020
  4. Study completion28 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03711409
Sponsor's protocol ID
TCHIRB-10705119-E
Status last verified
Aug 2021
First submitted
6 Aug 2018
Last updated
1 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Soft tissue biased manual therapy group and Conventional physical therapy group in people with Frozen Shoulder and Shoulder Adhesive Capsulitis, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Scapulo-humeral rhythm (scapular kinematics) during functional movements (time frame: Baseline and after 6-week intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.

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