NCT04993092

Brief Summary

this study will be a randomized clinical trial. This study will be conducted in Nishat Latif Hospital, Barath, Sialkot. A sample size of 22 patients will be taken. Patients will be divided into two groups by lottery method. Group A will be treated with mulligan mobilization technique and conventional physiotherapy with Transcutaneous electrical nerve stimulation and electrical heating pad. Group B will be treated with muscle energy technique and conventional treatment of Transcutaneous electrical nerve stimulation and electrical hot pack. Both groups will receive treatment for5 weeks,2 sessions in a week with baseline and 6 weeks treatment reading will be taken. The outcome measures Numeric pain rating scale, disabilities of the arm, shoulder and hand, Shoulder Pain and Disability Index . data will be analyzed by Statistical Package for the Social Sciences 25.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

July 19, 2021

Last Update Submit

August 27, 2021

Conditions

Keywords

Frozen shoulder

Outcome Measures

Primary Outcomes (3)

  • The Quick Disabilities of the Arm, Shoulder and Hand

    The Quick Disabilities of the Arm, Shoulder and Hand only contains subset of 11 items. it is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated The scores range from 0 (no disability) to 100 (most severe disability).

    4th week

  • The Shoulder Pain and Disability Index

    it is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with activity of daily living requiring the use of the upper extremities. The pain subscale is a composite measure and has 5-items and the Disability subscale is a composite measure and has 8-items. Total pain score (which is composite measure): / 50 x 100 = % (Note: If a person does not answer all questions divide by the total possible score, eg. if 1 question missed divide by 40) Total disability score (which is composite measure): / 80 x 100 = % (Note: If a person does not answer all questions divide by the total possible score, eg. if 1 question missed divide by 70) Total Shoulder Pain and Disability score: / 130 x 100 = % (Note: If a person does not answer all questions divide by the total possible score, eg. if 1 question missed divide by 120) The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).

    4th week

  • Goniometry

    To measure Range of Motion at Shoulder joint.

    4th week

Secondary Outcomes (1)

  • Numeric pain rating scale

    4th week

Study Arms (2)

mulligan mobilization technique

EXPERIMENTAL

Sustain Posterolateral glide with belt and then told Patient to move in following pattern (internal rotation, external rotation, abduction, wall sliding)

Other: mulligan mobilization technique

muscle energy technique

ACTIVE COMPARATOR

Post facilitation stretch Patient perform isometrics for 15 seconds then therapist rapidly move the shoulder to the end range

Other: muscle energy technique

Interventions

Post facilitation stretch Patient perform isometrics for 15 seconds then therapist rapidly move the shoulder to the end range

muscle energy technique

Sustain Posterolateral glide with belt and then told Patient to move in following pattern (internal rotation, external rotation, abduction, wall sliding)

mulligan mobilization technique

Eligibility Criteria

Age40 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pain in shoulder for at least 3 months
  • Unilateral frozen shoulder of stage 3 and 4
  • Capsular pattern i.e. (lateral rotation, Abduction, Medial rotation)

You may not qualify if:

  • Secondary capsulitis
  • Shoulder injury such as proximal humerus fracture.
  • History of Neurological deficit i.e. cervical stenosis, myelopathy.
  • Prolong immobilization due to cardiothoracic surgery, neurosurgery.
  • Shoulder surgical history such as shoulder arthroplasty.
  • History of other pathological condition of shoulders i.e. Impingement syndrome, rotator cuff tear or any shoulder injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sumaira Nawaz

Sialkot, Sialkot,Punjab,Pakistan, Pakistan

Location

Related Publications (9)

  • Goodridge JP. Muscle energy technique: definition, explanation, methods of procedure. J Am Osteopath Assoc. 1981 Dec;81(4):249-54. No abstract available.

    PMID: 7319853BACKGROUND
  • Campbell SM, Winkelmann RR, Walkowski S. Osteopathic manipulative treatment: novel application to dermatological disease. J Clin Aesthet Dermatol. 2012 Oct;5(10):24-32.

    PMID: 23125887BACKGROUND
  • Jain TK, Sharma NK. The effectiveness of physiotherapeutic interventions in treatment of frozen shoulder/adhesive capsulitis: a systematic review. J Back Musculoskelet Rehabil. 2014;27(3):247-73. doi: 10.3233/BMR-130443.

    PMID: 24284277BACKGROUND
  • Yeganeh Lari A, Okhovatian F, Naimi Ss, Baghban AA. The effect of the combination of dry needling and MET on latent trigger point upper trapezius in females. Man Ther. 2016 Feb;21:204-9. doi: 10.1016/j.math.2015.08.004. Epub 2015 Aug 14.

    PMID: 26304789BACKGROUND
  • Jones S, Hanchard N, Hamilton S, Rangan A. A qualitative study of patients' perceptions and priorities when living with primary frozen shoulder. BMJ Open. 2013 Sep 26;3(9):e003452. doi: 10.1136/bmjopen-2013-003452.

    PMID: 24078753BACKGROUND
  • Solomonow M, Krogsgaard M. Sensorimotor control of knee stability. A review. Scand J Med Sci Sports. 2001 Apr;11(2):64-80. doi: 10.1034/j.1600-0838.2001.011002064.x.

    PMID: 11252464BACKGROUND
  • Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.

    PMID: 32202646BACKGROUND
  • Doner G, Guven Z, Atalay A, Celiker R. Evalution of Mulligan's technique for adhesive capsulitis of the shoulder. J Rehabil Med. 2013 Jan;45(1):87-91. doi: 10.2340/16501977-1064.

    PMID: 23037929BACKGROUND
  • Nicholson GG. The effects of passive joint mobilization on pain and hypomobility associated with adhesive capsulitis of the shoulder. J Orthop Sports Phys Ther. 1985;6(4):238-46. doi: 10.2519/jospt.1985.6.4.238.

    PMID: 18802309BACKGROUND

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Muhammad Sanaullah, MS

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 19, 2021

First Posted

August 6, 2021

Study Start

January 10, 2021

Primary Completion

August 10, 2021

Study Completion

August 10, 2021

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations