NCT03791892

Brief Summary

Those shoulder patients who fulfill inclusion criteria are divided into two groups. Supervised exercises will be performed by both groups. Kaltenborn mobilization will be applied to patient in experimental group only. Assessment will be done on baseline, 7th and post visit. A total 38 subjects were included in study who met inclusion criteria. Number of patients in both groups was 19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 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

December 15, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 31, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

May 16, 2019

Status Verified

May 1, 2019

Enrollment Period

5 months

First QC Date

December 31, 2018

Last Update Submit

May 15, 2019

Conditions

Keywords

Adhesive capsulitissuprascapular nerveshoulder mobilization

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Rating Scale

    NPRS) is a scale used to find the level of pain intensity. At the time of treatment session intensity of pain is mainly the center of attention of the treatment. This pain scale is used in routine in clinical setting during the application of treatment procedure to evaluate the intensity of pain. NPRS has good validity and reliability. In our study we evaluate the status of pain in shoulder in individuals with adhesive capsulitis. The NPRS is a segmented numeric version of the visual analog scale in which a respondent selects the whole number (0-10). '0' indicates no pain whereas '10' indicates extreme pain. In our study NPRS values are taken at base line, 7th visit and post visit

    change from baseline.This tool is used to measure pain intensity

  • Goniometer

    In physical therapy goniometer is utilized to measures range of movement joint angles in the body.

    change from baseline.This tool is used to measure shoulder ranges

Secondary Outcomes (1)

  • SHOULDER PAIN AND DISABILITY INDEX (SPADI)

    change from baseline.This tool is used to measure shoulder disability

Study Arms (2)

Shoulder mobilization Group

EXPERIMENTAL

Kaltenborn mobilization will be applied to patient in experimental group only.

Other: Shoulder mobilization Group

Conventional treatment Group

ACTIVE COMPARATOR

Application of conventional treatment that includes stretching and strengthening exercises of shoulder.

Other: Conventional Treatment Group

Interventions

Suprascapular nerve block administered every week to both groups. Joint mobilization (3 sets / 40 seconds hold / 30 seconds interval) Stretching exercises (3 sets / 30 seconds hold / 10 seconds interval) Strengthening exercises ( 3 sets / 15 reps)

Shoulder mobilization Group

Suprascapular nerve block administered every week to both groups. Daily Stretching exercises (3 sets / 30 seconds hold / 10 seconds interval) Daily Strengthening exercises ( 3 sets / 15 reps)

Conventional treatment Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 to 70 years
  • Both male and female
  • Unilateral cases.
  • Grade 1 and 2 phase of adhesive shoulder

You may not qualify if:

  • Traumatic /fracture in upper extremity
  • Patients with malignancy
  • Post-operative shoulder
  • Patient under steroid therapy
  • Bilateral cases.
  • Grade 3 stage of frozen shoulder.
  • Patient with sever osteo-arthritis
  • Patient with diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Imran Amjad

Islamabad, Punjab Province, 46000, Pakistan

Location

Riphah International University

Islamabad, 44000, Pakistan

Location

Related Publications (7)

  • Tighe CB, Oakley WS Jr. The prevalence of a diabetic condition and adhesive capsulitis of the shoulder. South Med J. 2008 Jun;101(6):591-5. doi: 10.1097/SMJ.0b013e3181705d39.

    PMID: 18475240BACKGROUND
  • Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.

    PMID: 16282408BACKGROUND
  • Cho CH, Song KS, Kim BS, Kim DH, Lho YM. Biological Aspect of Pathophysiology for Frozen Shoulder. Biomed Res Int. 2018 May 24;2018:7274517. doi: 10.1155/2018/7274517. eCollection 2018.

    PMID: 29992159BACKGROUND
  • Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28.

    PMID: 20110457BACKGROUND
  • Siegel LB, Cohen NJ, Gall EP. Adhesive capsulitis: a sticky issue. Am Fam Physician. 1999 Apr 1;59(7):1843-52.

    PMID: 10208704BACKGROUND
  • Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.

    PMID: 16356983BACKGROUND
  • Baums MH, Spahn G, Nozaki M, Steckel H, Schultz W, Klinger HM. Functional outcome and general health status in patients after arthroscopic release in adhesive capsulitis. Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):638-44. doi: 10.1007/s00167-006-0203-x. Epub 2006 Oct 10.

    PMID: 17031613BACKGROUND

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • imran Amjad, phd*

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 31, 2018

First Posted

January 3, 2019

Study Start

December 15, 2018

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

May 16, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations