NCT04603768

Brief Summary

This project was a Randomized control trial conducted to check the effects of in patients with chronic frozen shoulder theraband, isometric and co-contraction exercises so that we can have best treatment option for patients with chronic frozen shoulder. upper cross syndrome, duration was of 6months,convenient sampling was done, subject following eligibility criteria from DHQ hospital Sheikhupura, were randomly allocated in three groups via lottery method, baseline assessment was done, Group A participants were given baseline treatment along with theraband exercises , Group B participants were given baseline treatment along with co-contraction exercises and Group C were given baseline treatment along with isometric exercises on 3rd and 6th week, post intervention assessment was done via, Numeric pain rating scale(NPRS),Shoulder Pain And Disability Index (SPADI) and goniometric measurements of shoulder ranges ,3 sessions per week were given, data was analyzed by using SPSS version 26.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

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

December 30, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

October 19, 2020

Last Update Submit

October 26, 2020

Conditions

Keywords

TherabandCo-contraction IsometricFrozen Shoulder

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain rating scale (NPRS)

    Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain

    3rd day

Secondary Outcomes (1)

  • SPADI

    3rd day

Other Outcomes (1)

  • Goniometric measurement of Shoulder ROM

    3rd day

Study Arms (3)

Theraband exercises

EXPERIMENTAL

Group A: baseline physical therapy treatment along with theraband exercises

Other: Theraband exercises

Co-contraction exercises

EXPERIMENTAL

Group B: baseline physical therapy treatment along with co-contraction exercises

Other: Co-contraction exercises

isometric exercises

EXPERIMENTAL

Group C: baseline physical therapy treatment along with isometric exercises

Other: Isometric exercises

Interventions

Group A performed theraband exercises for 6 weeks.In the first 2 weeks theraband with low resistance was used to perform exercises and then we proceeded gradually with higher resistance therabands.Theraband exercises was performed for Shoulder Flexion,Shoulder Extension Strengthening, Shoulder Internal Rotation Strengthening, Shoulder External Rotation Strengthening, Shoulder Abduction, Empty Can Exercise \& Rowing Exercise with 8-10 reps, 3sec hold and 2-3 sets With each of these exercises

Theraband exercises

Muscle co-contraction is the simultaneous contraction of the muscles acting around a joint. Subject stood upright \& contracted both the groups (agonist and antagonist) simultaneously without bringing movement at shoulder joint with 6-8 reps , 3sets \& 5- 15 seconds duration of sustained self-arm bracing or stiffening was maintained. On eligible participants baseline assessment was done,3 session were given 3days per week, post intervention assessment was taken at 3rd and 6th week

Co-contraction exercises

Isometric exercises of shoulder were performed in subjects for 6 weeks which included isometric Shoulder flexion, shoulder abduction isometric exercise, isometric shoulder external rotation, isometric shoulder internal rotation \& isometric shoulder extension with 8-10 reps, 5 sec hold and 2 sets. On eligible participants baseline assessment was done,3 session were given 3days per week, post intervention assessment was taken at 3rd and 6th week

isometric exercises

Eligibility Criteria

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

You may qualify if:

  • Idiopathic with 6 month chronicity.
  • Patients with AROM/PROM less than or equal to 90 degrees.
  • Affected shoulder has not more than 90 degrees of abduction \& 50% decreased external rotation as compared to normal side/normal ROM values.

You may not qualify if:

  • Traumatic \& diabetic.
  • Patient with any cervical or thoracic problem.
  • Patients with any intra-articular injection in glenohumeral joint.
  • Patients with rotator cuff complete tear.
  • Patients with any other serious pathology/red flags

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ hospital

Sheikhupura, Punjab Province, Pakistan

Location

Related Publications (9)

  • Chan HBY, Pua PY, How CH. Physical therapy in the management of frozen shoulder. Singapore Med J. 2017 Dec;58(12):685-689. doi: 10.11622/smedj.2017107.

    PMID: 29242941BACKGROUND
  • Cho CH, Bae KC, Kim DH. Treatment Strategy for Frozen Shoulder. Clin Orthop Surg. 2019 Sep;11(3):249-257. doi: 10.4055/cios.2019.11.3.249. Epub 2019 Aug 12.

    PMID: 31475043BACKGROUND
  • Moradi M, Hadadnezhad M, Letafatkar A, Khosrokiani Z, Baker JS. Efficacy of throwing exercise with TheraBand in male volleyball players with shoulder internal rotation deficit: a randomized controlled trial. BMC Musculoskelet Disord. 2020 Jun 13;21(1):376. doi: 10.1186/s12891-020-03414-y.

    PMID: 32534582BACKGROUND
  • Hanchard N. Exercise classes supervised by a physiotherapist may be better at restoring function after frozen shoulder than individual physiotherapy. J Physiother. 2014 Dec;60(4):236. doi: 10.1016/j.jphys.2014.08.011. Epub 2014 Oct 23. No abstract available.

    PMID: 25439717BACKGROUND
  • Lin HC, Li JS, Lo SF, Shih YF, Lo CY, Chen SY. Isokinetic characteristics of shoulder rotators in patients with adhesive capsulitis. J Rehabil Med. 2009 Jun;41(7):563-8. doi: 10.2340/16501977-0378.

    PMID: 19543668BACKGROUND
  • Shishir M, Abraham MM, Kanagasabai R, Najimudeen S, Gnanadoss JJ. Home Based Exercise Program for Frozen Shoulder-Follow-up of 36 Idiopathic Frozen Shoulder Patients. Indian Journal of Physiotherapy and Occupational Therapy. 2013;7(3):221.

    BACKGROUND
  • Alptekin HK, Aydin T, Iflazoglu ES, Alkan M. Evaluating the effectiveness of frozen shoulder treatment on the right and left sides. J Phys Ther Sci. 2016 Jan;28(1):207-12. doi: 10.1589/jpts.28.207. Epub 2016 Jan 30.

    PMID: 26957759BACKGROUND
  • Roach KE, Budiman-Mak E, Songsiridej N, Lertratanakul Y. Development of a shoulder pain and disability index. Arthritis Care Res. 1991 Dec;4(4):143-9.

    PMID: 11188601BACKGROUND
  • Sato H, Maruyama H. The Effects of Indirect Treatment of Proprioceptive Neurosmuscular Facilitation. Journal of Physical Therapy Science. 2009;21(2):189-

    BACKGROUND

MeSH Terms

Conditions

Bursitis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Syed Shakil Ur-Rehman, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2020

First Posted

October 27, 2020

Study Start

December 30, 2019

Primary Completion

August 30, 2020

Study Completion

September 30, 2020

Last Updated

October 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations