NCT05649410

Brief Summary

Adhesive capsulitis is a condition characterized by progressive declination range of motion at the glenohumeral joint due to tightness of capsule. The joint capsule and its surrounding connective tissue becomes stiffed, inflamed and shortened which in return causes decrease in range of motion that progress to chronic pain and stiffness. Adhesive capsulitis is a self-limiting disorder that resolves within 1-3 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

December 6, 2022

Last Update Submit

December 12, 2024

Conditions

Keywords

painsleeper stretchmobilization with movementrange of motion

Outcome Measures

Primary Outcomes (4)

  • NPRS (Numeric Pain Rating Scale)

    The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable. intraclass correlation coefficient = 0.74 for shoulder pain.

    four weeks

  • Goniometer

    Shoulder range of motion i.e. Shoulder Flexion, Extension, Abduction, Adduction, Internal rotation, External rotation will be measured using goniometer, intraclass correlation coefficient for using goniometer for shoulder joint Range Of Motion ranges from 0.91 to 0.99

    four weeks

  • SPADI (Shoulder Pain and Disability Index)

    The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with Activities of Daily Livings requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items. The patient is instructed to choose the number that best describes their level of pain and extent of difficulty using the involved shoulder. The pain scale is summed up to a total of 50 while the disability scale sums up to 80. The total SPADI score is expressed as a percentage. A score of 0 indicates best 100 indicates worst. A higher score shows more disability. SPADI is reliable for subjects with Adhesive capsulitis, intraclass correlation coefficient for pain scale=0.989 and intraclass correlation coefficient for disability=0.990

    four weeks

  • Scapulohumeral Rhythm

    Scapular upward rotation will be measured using inclinometer placed at the spine of scapula. Patient will be advised to perform shoulder abduction and measurements will be taken at 3 degrees i.e. 0 to 45degree, 0 to 90 degree, 0 to 120 degree. 3 measurements will be taken at each range and then their mean will be calculated. Scapulohumeral rhythm will be measured by dividing humeral elevation with scapular upward rotation. Scapulohumeral rhythm=humeral elevation/scapular upward rotation. The intraclass correlation coefficient for measuring Scapulohumeral rhythm using inclinometer is \> 0.892.

    four weeks

Study Arms (2)

mobilization with movement and conventional therapy

EXPERIMENTAL

Mobilization with movement for Flexion, Abduction, Internal rotation, external rotation

Other: mobilization with movement and conventional therapy

sleeper stretch along with conventional therapy

EXPERIMENTAL

IT will be performed with the patient in side lying on the affected side to stabilize the scapula against the table and both the shoulder and elbow flexed to 90°.In this position, passive Internal Rotation is applied to the affected shoulder by the therapist or patients opposite hand.

Other: sleeper stretch along with conventional therapy

Interventions

Mobilization with movement for Flexion, Abduction, Internal rotation, external rotation

mobilization with movement and conventional therapy

it will be performed with the patient in side lying on the affected side to stabilize the scapula against the table and both the shoulder and elbow flexed to 90°.In this position, passive Internal Rotation is applied to the affected shoulder by the therapist or patients opposite hand.

sleeper stretch along with conventional therapy

Eligibility Criteria

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

You may qualify if:

  • Patients with Adhesive Capsulitis of stage 1 and 2.
  • Patients with idiopathic adhesive capsulitis.
  • Patients with unilateral involvement having painful stiff shoulder for 3 or more months without any shoulder trauma.
  • Marked loss in active and passive Range of Motion (Abduction, external and internal rotation) minimum 50% compared to the unaffected side.
  • cm asymmetry on bilateral comparison during lateral scapular slide test.

You may not qualify if:

  • Patients with shoulder pain due to neurological abnormalities e.g. Hemiplegia.
  • Patients with Rotator cuff injury or tear.
  • Recent trauma to upper limb.
  • Disorders of bones such as fractures, osteoporosis, glenohumeral arthritis.
  • Cervical spondylosis or cervical radiculopathy.
  • Any malignancy or tumor.
  • Patients having any intra articular injection in the gleno-humeral joint during last three months.
  • Patients with cardiovascular impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Physiotherapy clinic Saidpur Road

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

BursitisPain

Interventions

Movement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • maria Khalid, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 14, 2022

Study Start

January 1, 2023

Primary Completion

July 10, 2023

Study Completion

July 10, 2023

Last Updated

December 17, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations