NCT06674408

Brief Summary

The purpose of the study is to explore the effect of proprioceptive and hand function exercises in management of acute adhesive capsulitis. A randomized control trial was conducted at RIH Sihala, DSK Bahria town phase 7 and MRC MIHS Rawalpindi. The sample size was 44 calculated through G-power 3.1. The participants were divided into two interventional groups each having 22 participants. The study duration was six months. Sampling technique applied was convenience sampling for recruitment and group randomization using flip coin method. Only 35 to 50 years participants with acute adhesive capsulitis were included in the study. Tools used in this study are Goniometer, NPRS, SPADI and DASH. Data was collected at baseline, at the end of 1st week and 2nd week. Data analyzed through SPSS version 26.

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 May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2024

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

November 3, 2024

Last Update Submit

December 12, 2024

Conditions

Keywords

adhesive capsulitisfrozen shoulder

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Rating Scale

    Changes from Baseline pain values were taken with the help of Numeric Pain Rating Scale measures level of pain. Scoring is done by selecting a point from zero to ten as the current level of pain. Zero means minimum pain and 10 denotes maximum pain.

    2nd Week

  • Range of motion

    Changes from Baseline shoulder range of motion taken with the help of universal goniometer

    2nd Week

Secondary Outcomes (2)

  • Shoulder Pain and Disability Index

    2nd Week

  • Disability of Arm, Shoulder and Hand

    2nd Week

Study Arms (2)

Prioprioceptive exercises

EXPERIMENTAL

Hot packs, mobilization, stretching and strengthening, closed and open chain kinetic exercises, hand function exercises, hand eye coordination exercises

Other: Prioprioceptive group

Conventional

ACTIVE COMPARATOR

Hot packs, mobilization, stretching and strengthening, finger ladder exercise, Codman's pendulum exercise, towel stretch exercise and wand exercises

Other: Traditional physical therapy

Interventions

Control group included Hot pack over shoulder region for 15 mins. Shoulder AP, PA and inferior glides (Maitland) Grade II, III, IV 30 reps x 3 sets per session, Stretching of levator scapula, upper trapezius, pectoralis major and minor with 15 second hold x 3 reps per session, Strengthening of rotator cuff muscles by manual resistance with 10 second hold x 5 reps x 2 sets per muscle per session, Finger Ladder Exercise, Codman's Pendulum Exercise, Towel Stretch Exercise and Wand Exercises 10 reps x 2 sets per session, Patients were assessed for baseline measurements against outcome measures. Patients were given a total of 10 sessions such that 5 sessions per week for the duration of 02 weeks. All patients were reassessed at the end of the 1st and 2nd week of treatment for outcome measures.

Conventional

Experimental group included Hot pack over shoulder region for 15 mins. Shoulder AP, PA and inferior glides (Maitland) Grade II, III, IV 30 reps x 3 sets per session, Stretching of levator scapula, upper trapezius, pectoralis major and minor with 15 second hold x 3 reps per session, Strengthening of rotator cuff muscles by manual resistance with 10 second hold x 5 reps x 2 sets per muscle per session, Plyometric CKC shoulder exercise 10 seconds each x 5 reps x 2 sets per session, CKC exercise on the ball 10 seconds each x 5 reps x 2 sets per session, Open KC exercises 10 seconds each x 5 reps x 2 sets per session, Hand-eye coordination exercises for 30 minutes/per day for 5x/per week, Hand Function Exercises for 30 minutes/per day for 5x/per week. Patients were assessed for baseline measurements against outcome measures. Patients were given a total of 10 sessions such that 5 sessions per week for the duration of 02 weeks. All patients were reassessed at the end of the 1st and 2nd week

Prioprioceptive exercises

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Painful and limited active and passive glenohumeral ROM
  • Freezing or acute stage of adhesive capsulitis
  • Positive Coracoid pain and DTPER tests
  • Primary adhesive capsulitis/secondary due to diabetes mellitus
  • Consenting to participate in the study

You may not qualify if:

  • Bilateral adhesive capsulitis
  • Sub-acute and chronic stages of adhesive capsulitis
  • Unstable fractures or surgical fixation in the affected limb
  • Rheumatoid arthritis
  • Severe joint pain unrelieved by rest
  • Osteoporosis
  • Radiating pain due to cervical conditions
  • Manipulations under anesthesia
  • Shoulder conditions such as subacromial pain syndrome, rotator cuff tendinopathy, shoulder bursitis etc.
  • Neurological damage due to stroke or Parkinsonism
  • Cognitive deficits and not giving consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Riphah International Hospital

Islamabad, Pakistan

Location

DSK Physio and Rehab

Rawalpindi, Pakistan

Location

Margalla Rehab Center

Rawalpindi, Pakistan

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Muhammad Affan Iqbal, PhD

    Riphah International University, Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 3, 2024

First Posted

November 5, 2024

Study Start

May 3, 2024

Primary Completion

December 3, 2024

Study Completion

December 3, 2024

Last Updated

December 17, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations