NCT04157387

Brief Summary

The objective of study is to find out the effectiveness of cyriax capsular stretching in idiopathic adhesive capsulitis and to find out the combined effect of capsular stretching's, mobilization and conservative treatment on pain and Range of Motion (ROM) in idiopathic adhesive capsulitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

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

Study Start

First participant enrolled

January 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

November 6, 2019

Last Update Submit

January 8, 2020

Conditions

Keywords

Adhesive CapsulitisCyriax Manual TherapyStretching

Outcome Measures

Primary Outcomes (3)

  • Goniometer

    Changes from the baseline, Measure the available range of motion or the position of the shoulder joint - typically this is a measure of passive motion like External Rotation, External Rotation and Internal Rotation.

    3rd week

  • Visual Analogue Scale (VAS)

    Changes from the baseline, Normative values are not presented so by using a ruler , the score is calculated by measure the distance on 10cm line between the "no pain" point and the patient's mark, provide a range of score from 0-100. A higher score indicates greater pain intensity.

    3rd Week

  • Shoulder pain and disability index (SPADI)

    Changes from the Baseline, SPADI is a self-administered questionnaire that aims to measure pain and disability associated with shoulder disease. It consists of two dimensions, one for pain and second for functional activities. The pain element consists of five questions regarding severity of pain and to measure the degree of severity that an individual faced during various activities of daily life that involve upper extremity use. There are eight questions. Each subscale is summed up and a total SPADI score is expressed as a percentage.Total pain score : --/50 ×100 = %, Total disability score: --/80 × 100 = %, Total SPADI score: --/130 × 100 = %. A score of 0 indicates best 100 indicates worst. A higher score shows more disability.

    3rd week

Study Arms (2)

Cyriax inferior capsular stretching + Manual Therapy

EXPERIMENTAL

Cyriax inferior capsular stretching \+ Electrotherapy Manual therapy : Kaltenborn grade 1 and 2 Mobilization Active ROM exercises : Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction

Other: Cyriax inferior capsular stretching + Manual Therapy

Manual Therapy

ACTIVE COMPARATOR

Analgesic short-wave diathermy Manual Therapy: Kalternbon grade 1 and 2 Mobilization :, Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction.

Other: Manual therapy

Interventions

Electro-therapy 10mins Manual therapy : Kalternbon grade 1 and 2 Mobilization : Inferior glide (10x3), posterior glide, (10 reps x 3 sets), anterior glide (10 reps x 3 sets), Active ROM exercises : 10 reps x 3 sets Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction (10reps x 2 sets ,each) Cyriax inferior capsular stretching

Cyriax inferior capsular stretching + Manual Therapy

Before starting capsule stretching technique, Analgesic short-wave diathermy may be given for 10 minutes. Kalternbon grade 1 and 2 Mobilization : Inferior glide (10x3), posterior glide, (10 reps x 3 sets), anterior glide (10 reps x 3 sets), Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction (10reps x 2 sets ,each)

Manual Therapy

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Adhesive capsulitis phase 1 and phase 2
  • Follow capsular pattern ( ER \> Abduction\> IR)

You may not qualify if:

  • Adhesive capsulitis phase 3
  • Any intrinsic etiology i.e. rheumatoid arthritis,
  • infection,
  • gout,
  • haemarthrosis or
  • tumor or Arthritis in stage III or in stage II with a spastic end-feel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International university

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Bursitis

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Abdul Ghafoor Sajjad, Phd*

    Riphah International University

    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 6, 2019

First Posted

November 8, 2019

Study Start

January 1, 2018

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

January 10, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations