NCT06407817

Brief Summary

To compare the effects of spencer and reverse distraction technique in patients with adhesive capsulitis

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

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

February 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

May 6, 2024

Last Update Submit

December 20, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • pain : numerical pain rating scale

    Patients' overall assessment of pain will be provided using the numeric pain rating scale (NPRS). The NPRS is known to be a sensitive and reliable scale for clinical and experimental evaluation of pain intensity. The score ranges from 0, indicating no pain, to 10, expressing worst imaginable pain. The reliability of numeric pain rating scale (NPRS) is 0.92 (0.87, 0.95).

    6 weeks

  • range of motion : universal goniometer

    Universal Goniometer is the most commonly utilised clinical tool for measuring joint range of motion due to its ease of use, low cost, and demonstrated reasonable levels of reliability and validity in numerous studies. Validity and intertester reliability (r =.97-.98; ICC =.98-.99) are both high

    6 weeks

  • shoulder pain and impairment : SPADI

    The SPADI consists of 13 items that assess two domains: a 5-item subscale for pain and an 8-item subscale for disability. The SPADI has since been used in both primary care on mixed diagnosis and surgical patient populations including rotator cuff disease, osteoarthritis, and rheumatoid arthritis, adhesive capsulitis ,joint replacement surgery , and in a large population-based study of shoulder symptoms (37). Reliability- 0.89, Validity - 0.90

    6 weeks

  • 36-Item Short Form Health Survey questionnaire (SF-36)

    The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. The ICC for SF-36 PF is (0.96, 95% CI 0.92-0.98) so it's a reliable test.

    6 weeks

Study Arms (2)

Spencer's technique

EXPERIMENTAL

This group will receive the Spencer's technique.

Procedure: Spencer techniqueProcedure: reverse distraction technique

reverse distraction technique

ACTIVE COMPARATOR

This group will recieve reverse distraction technique

Procedure: Spencer techniqueProcedure: reverse distraction technique

Interventions

No of repetitions; 3 sets for 10 repetitions with 1 minute rest between sets No Of Sessions Per Week: 3 Per Weeks for 6 weeks (40 Min per Session)

Spencer's techniquereverse distraction technique

No of repetitions; 10 ( Shoulder Abduction)10 ( Shoulder Flexion) 10 (Shoulder External Rotation) No Of Sessions Per Week: 3 Per Weeks for 6 weeks (40 Min Per Session)

Spencer's techniquereverse distraction technique

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age group 40-60 years
  • Male and female
  • Positive Capsular pattern (ER more limited than Abd which is more limited than IR)
  • Limitation in shoulder ROM ; Flexion \<180 , Abduction \<180 , External Rotation \<50
  • Patients of stage 2 and 3 of adhesive capsulitis

You may not qualify if:

  • History of surgery of the affected shoulder
  • Fractures in around the shoulder
  • Neurological disorders leading to altered muscle activity
  • Systemic arthritic conditions (RA, Osteoporosis)
  • Disorders of the cervical spine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johar Pain Relief Center

Lahore, Punjab Province, 54782, Pakistan

RECRUITING

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Rabiya Noor, PHD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Minal Mushtaq, MS-DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

February 1, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations