NCT06387537

Brief Summary

Adhesive capsulitis is a common musculoskeletal condition. Painful gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.Scapular position and movement perception both effected by shoulder adhesive capsulitis, change in the scapular kinematics in the form of an increase in scapular lateral rotation, and reduced joint sense for shoulder movements in adhesive capsulitis. Physiotherapists have a wide range of options in managing Adhesive capsulitis including Electrotherapeutic modalities, kaltenborn mobilization, Maitland's mobilization,Mulligan's mobilization and Manipulation. So far studies have shown the efficacy of different treatments in combination or in isolation.Few studies on proprioception in rotator cuff tear, sub acromial impingment syndrome, but no obseved effects of scapular mobilization on shoulder proprioception in patients with adhesive capsulitis.Physical therapist focus on lowering pain and ROM limitations in the shoulder,but often neglect to evaluate proprioception/joint position sense as well as the roleof scapula in adhesive capsulitis during treatment.If found effective,this study can help in probviding treatment protocols for improving proprioception in patients with adhesive capsulits.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

April 23, 2024

Last Update Submit

April 23, 2024

Conditions

Keywords

Chronic pain, proprioception, scapular mobilization

Outcome Measures

Primary Outcomes (2)

  • Shoulder Proprioception

    Proprioception will be measured using the universal Goniometer which is 0 to 180 degree for half circle model or 0 to 360 degree for full circle models.

    4 weeks

  • Pain Intensity

    Pain will be assessed using Visual Analog scale which is 0-100 item scale.

    4 weeks

Secondary Outcomes (2)

  • Shoulder Range of motion

    4 weeks

  • Shoulder Disability

    4 weeks

Study Arms (2)

Group A (Conventional Physical Therapy )

ACTIVE COMPARATOR

Patients in this group will receive conventional physical therapy including Hot pack for 10 to 15 minutes, ROM exercises such as Internal \& external rotation, Extension in standing, Pulley for elevation in sitting or standing, Forward flexion in supine using own head, pendulum (1min clockwise, 1 min anti clock wise),these are Low intensity, short duration, 1-5 sec, 2-3 times/day, pain free passive, AAROM. GH mobilization: kaltenborn low grade mobilization (grade I or II) for (1 minute), Then mobilization with movement 3 sets of 10 reps with 1 minute rest in between will be given.Strengthening exercises include Isometric in all planes, 5 second holds, 1 set of 10 each direction, against wall. Every session will be given for 30 minutes and a total of 12 sessions would be conducted over a period of 4 weeks.

Procedure: Conventional physical therapy

Group B (Conventional physical therapy and Scapular mobilization)

EXPERIMENTAL

Patients will receive scapular mobilization in addition to conventional physical therapy including Hot pack for 10 to 15 minutes , ROM exercises such as Internal \& external rotation, Extension in standing, Pulley for elevation in sitting or standing, Forward flexion in supine using own head, pendulum (1min clockwise, 1 min anti clock wise),these are Low intensity, short duration, 1-5 sec, 2-3 times/day, pain free passive, AAROM. GH mobilization: kaltenborn low grade mobilization (grade I or II) for (1 minute), Then mobilization with movement 3 sets of 10 reps with 1 minute rest in between will be given. Strengthening exercises include Isometric in all planes, 5 second holds, 1 set of 10 each direction, against wall. Scapular Mobilizations Glides- superior, inferior, distraction, upward and downward rotation (5 sets, 10 reps, 30 sec break in 1 session).Every session will be given for 30 minutes and a total of 12 sessions would be conducted over a period of 4 consecutive weeks.

Procedure: Conventional physical therapyProcedure: Scapular mobilization.

Interventions

Patients in this group will recieve hot pack, ROM exercises, strengthening exercises and Kaltenborn mobilizations. A total of 12 sessions, 3 sessions per week for 4 consecutive weeks. Sets and repetitions will be increased progressively.

Group A (Conventional Physical Therapy )Group B (Conventional physical therapy and Scapular mobilization)

Scapular Mobilizations: Glides- superior, inferior, distraction, upward and downward rotation (5 sets, 10 reps, 30 sec break in 1 session).Every session will be given for 30 minutes and a total of 12 sessions would be conducted over a period of 4 consecutive weeks.

Group B (Conventional physical therapy and Scapular mobilization)

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with Nonspecific adhesive capsulitis without specific identifiable etiology (i.e. infection, inflammatory disease)
  • years of age both males and females.
  • Chronic shoulder pain \> 3 months.

You may not qualify if:

  • Patients with other shoulder joint pathologies, such as fractures or dislocations, glenohumeral instability or rotator cuff pathologies in the affected shoulder.
  • Subjects who have undergone surgery or have experienced an acute trauma to the shoulder.
  • Individuals with current or history of neurological disorders (such as stroke, Alzheimer's, or Parkinson's), rheumatologic diseases (such as rheumatoid arthritis or systemic lupus erythematous), or systemic illnesses (such as thyroid disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 460000, Pakistan

RECRUITING

MeSH Terms

Conditions

BursitisChronic Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Mubeen Farooq, MS-MSKPT*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial having two groups. One group will receive conventional physical therapy and the second will receive conventional physical therapy along with scapular mobilization. Both groups will be recruited concurrently.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2024

First Posted

April 29, 2024

Study Start

March 1, 2024

Primary Completion

July 1, 2024

Study Completion

July 15, 2024

Last Updated

April 29, 2024

Record last verified: 2024-04

Locations