NCT04967911

Brief Summary

This project was a Randomized control trial conducted to check the Effects of Proprioceptive Neuromuscular Facilitation on Shoulder Pain due to chronic impingement syndrome in paraplegic Manual Wheelchair users after Spinal Cord Injury so that we can have best treatment option for patients with shoulder pain due to manual wheelchair usage. duration was of 6months,convenient sampling was done, subject following eligibility criteria from Spine welfare trust center, Nawaz Sharif social security Hospital were randomly allocated in two groups via lottery method, Group A participants were given baseline treatment along with PNF exercises , Group B participants were given baseline treatment upto 6 weeks and 3 sessions per, post intervention assessment was done after 6 weeks, by self-generated questionnaire (WUSPI) wheel chair users shoulder pain index, (SRQ) Shoulder rating questionnaire and physical assessment by 2 special test was done, data was analyzed by using SPSS version 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 Nov 2020

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

November 30, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

July 19, 2021

Last Update Submit

July 19, 2021

Conditions

Keywords

Spinal cord injury, wheelchair users, Shoulder pain, PNF

Outcome Measures

Primary Outcomes (1)

  • Wheelchair User's Shoulder Pain Index

    The Wheelchair User's Shoulder Pain Index (WUSPI) was designed to measure shoulder pain in individuals who use wheelchairs. On the visual analog scale from ' 0' to '10 ' estimate level of pain with different activities

    6th Week

Secondary Outcomes (1)

  • Shoulder rating Questionnaire

    6th Week

Study Arms (2)

Rhythmic stabilization exercises

EXPERIMENTAL

baseline physical therapy conventional treatment along Rhythmic stabilization exercises

Other: Rhythmic stabilization exercises

Conventional treatment

OTHER

Baseline physical therapy conventional treatment

Other: conventional treatment

Interventions

PNF techniques and Conventional Treatment: Experimental group received rhythmical Stabilization Technique on shoulder joint on all shoulder movements up to 1 minute in supine position For stability of joint ,re-establish dynamic rotator cuff stability and to enhance MS strength and decrease pain. Conventional Treatment: heating pad for 15 minutes, TENS (Transcutaneous Electrical Nerve Stimulation) and after that shoulder stretching of upper trapezius muscle, pectorals and levator scapule and isometric exercises of rotator cuff muscles performed in supine .( 10 sec hold and 10 to 15 reps)..

Rhythmic stabilization exercises

Conventional Treatment: heating pad for 15 minutes, TENS (Transcutaneous Electrical Nerve Stimulation) and after that shoulder stretching of upper trapezius muscle, pectorals and levator scapule and isometric exercises of rotator cuff muscles performed in supine .( 10 sec hold and 10 to 15 reps)..

Conventional treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old paraplegic manual wheel chair users after spinal cord injury.
  • Those having level of injury from C7-T12
  • Patients who are using wheelchair from more than one year.
  • Pain perceived region of one or both Shoulder from last three months or more
  • Pain without radicular symptoms radiating to whole upper limbs.
  • Wheelchair propulsion in activities of daily living,
  • Individuals with positive Neer's test and Hawkins-Kennedy test

You may not qualify if:

  • Any red flags (tumor, fracture, metabolic diseases, rheumatoid arthritis, resting blood pressure greater than 140/90 mmHg, prolonged history of steroid use, etc.
  • Any dislocation ,muscular tear and acute problem of shoulder.
  • Presented with a diagnosis of cervical spinal stenosis, exhibited bilateral upper extremity symptoms
  • Any recent surgery of the shoulder
  • Individuals using other mobility devices with wheelchair.
  • Individuals with primary impingement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoora hospital, Lahore, Spine welfare centre, Social security hosital

Lahore, Punjab Province, Pakistan

Location

Related Publications (9)

  • Mason B, Warner M, Briley S, Goosey-Tolfrey V, Vegter R. Managing shoulder pain in manual wheelchair users: a scoping review of conservative treatment interventions. Clin Rehabil. 2020 Jun;34(6):741-753. doi: 10.1177/0269215520917437. Epub 2020 May 12.

    PMID: 32397819BACKGROUND
  • El Essi K, El-Shafie JM, Al Hawamdah Z, Zaqout SI. Shoulder Pain among Rehabilitated Spinal Cord Injured Persons Using Manually Propelled Wheelchairs in the Gaza Strip: A Survey. Disabil CBR Incl Dev. 2012;23(2):53-71.

    BACKGROUND
  • Soo Hoo J. Shoulder Pain and the Weight-bearing Shoulder in the Wheelchair Athlete. Sports Med Arthrosc Rev. 2019 Jun;27(2):42-47. doi: 10.1097/JSA.0000000000000241.

    PMID: 31046007BACKGROUND
  • Jain NB, Higgins LD, Katz JN, Garshick E. Association of shoulder pain with the use of mobility devices in persons with chronic spinal cord injury. PM R. 2010 Oct;2(10):896-900. doi: 10.1016/j.pmrj.2010.05.004.

    PMID: 20970758BACKGROUND
  • Samuelsson KA, Tropp H, Gerdle B. Shoulder pain and its consequences in paraplegic spinal cord-injured, wheelchair users. Spinal Cord. 2004 Jan;42(1):41-6. doi: 10.1038/sj.sc.3101490.

    PMID: 14713943BACKGROUND
  • Walford SL, Requejo PS, Mulroy SJ, Neptune RR. Predictors of shoulder pain in manual wheelchair users. Clin Biomech (Bristol). 2019 May;65:1-12. doi: 10.1016/j.clinbiomech.2019.03.003. Epub 2019 Mar 6.

    PMID: 30927682BACKGROUND
  • Giner-Pascual M, Alcanyis-Alberola M, Millan Gonzalez L, Aguilar-Rodriguez M, Querol F. Shoulder pain in cases of spinal injury: influence of the position of the wheelchair seat. Int J Rehabil Res. 2011 Dec;34(4):282-9. doi: 10.1097/MRR.0b013e32834a8fd9.

    PMID: 21971486BACKGROUND
  • Çitaker S, Taşkiran H, Akdur H, Arabaci ÜmÖ, Ekici G. Comparison of the mobilization and proprioceptive neuromuscular facilitation methods in the treatment of shoulder impingement syndrome. Pain Clin. 2005 Jun;17(2):197-202.

    BACKGROUND
  • Mulroy SJ, Thompson L, Kemp B, Hatchett PP, Newsam CJ, Lupold DG, Haubert LL, Eberly V, Ge TT, Azen SP, Winstein CJ, Gordon J; Physical Therapy Clinical Research Network (PTClinResNet). Strengthening and optimal movements for painful shoulders (STOMPS) in chronic spinal cord injury: a randomized controlled trial. Phys Ther. 2011 Mar;91(3):305-24. doi: 10.2522/ptj.20100182. Epub 2011 Feb 3.

    PMID: 21292803BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement SyndromeSpinal Cord InjuriesShoulder Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mehwish Ikram, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 19, 2021

First Posted

July 20, 2021

Study Start

November 30, 2020

Primary Completion

May 30, 2021

Study Completion

June 30, 2021

Last Updated

July 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations