Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Acute Effects of Pragmatic Manual Therapy on the Range of Motion of Shoulder Joint

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242888
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Isra University

Brief Summary:
Current studies on the mechanism of subacromial impingement and other shoulder pathology reveals that multiple factors are responsible for impingement. These includes serratus anterior dysfunction, rotator cuff insufficiency, posterior capsular tightness, acromio-clavicular join, thoracic spine stiffness and extensibility of the pectoralis minor and subclavius muscles. Manual intervention should therefore address these issues in conjunction with the other therapies. Novel interventions has been designed pilot tested for each of these factors to produce healing environment. The purpose of this study is to evaluate the effects of each individual factor and combination of all on the range of motion of shoulder joint in healthy subjects and subjects with restricted range of motion of shoulder joint respectively. Four trials of quasi experiment design for healthy each of 30 subject has been designed. Beneficial intervention among the four trials and other previously reported beneficial in improving the shoulder joint range will be combined in and termed as pragmatic interventions protocols. Pragmatic interventions on subjects with restricted range in shoulder pathology will be tested through similar design. Effects of these interventions on the Quality of life measured through Urdu version of Shoulder pain and disability in subjects with shoulder pathology will also be tested .

Condition or disease Intervention/treatment Phase
Shoulder Impingement Prehabilitation Rehabilitation Other: pragmatic manual therapies Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Four trial of a single group quasi experimental design on healthy subjects through individual intervention followed by similar trial on subject with shoulder pathology through combination of all intervention.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: participant and outcome assessor does not know the purpose of the trial
Primary Purpose: Treatment
Official Title: The Acute Effects of Pragmatic Manual Therapy on the Range of Motion of Shoulder Joint
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : January 1, 2021

Arm Intervention/treatment
Experimental: Rotator Cuff Facilitation
The function of Rotator cuff muscles is passively augmented in one of the 5 trials
Other: pragmatic manual therapies
three of the intervention are novel and the rest of the interventions are in practice but seldom used to treat the shoulder disorder.
Other Names:
  • Rotator cuff facilitation
  • Serratus anterior stretch
  • Acromioclavicular joint mobilization
  • Posterior capsular stretch
  • A set of pragmatic interventions

Experimental: Serratus Anterior Stretch
Seratus anterior muscles is stretched through a novel technique
Other: pragmatic manual therapies
three of the intervention are novel and the rest of the interventions are in practice but seldom used to treat the shoulder disorder.
Other Names:
  • Rotator cuff facilitation
  • Serratus anterior stretch
  • Acromioclavicular joint mobilization
  • Posterior capsular stretch
  • A set of pragmatic interventions

Experimental: Posterior Capsular Stertch
Posterior capsule is stretched through a novel maneuver
Other: pragmatic manual therapies
three of the intervention are novel and the rest of the interventions are in practice but seldom used to treat the shoulder disorder.
Other Names:
  • Rotator cuff facilitation
  • Serratus anterior stretch
  • Acromioclavicular joint mobilization
  • Posterior capsular stretch
  • A set of pragmatic interventions

Experimental: Acromioclavicular Joint Mobilization
Acromio clavicular joint is mobilized posterio-anterior
Other: pragmatic manual therapies
three of the intervention are novel and the rest of the interventions are in practice but seldom used to treat the shoulder disorder.
Other Names:
  • Rotator cuff facilitation
  • Serratus anterior stretch
  • Acromioclavicular joint mobilization
  • Posterior capsular stretch
  • A set of pragmatic interventions

Experimental: Pragmatic Interventions

The pragmatic interventions is a set of interventions which include

  1. Rotator cuff facilitation
  2. Posterior capsular stretch
  3. Serratus anterior muscle stretch
  4. Acromioclaicualr joint mobilization
  5. Thoracic spine manipulation and
  6. Stretch to the subclavious muscles
Other: pragmatic manual therapies
three of the intervention are novel and the rest of the interventions are in practice but seldom used to treat the shoulder disorder.
Other Names:
  • Rotator cuff facilitation
  • Serratus anterior stretch
  • Acromioclavicular joint mobilization
  • Posterior capsular stretch
  • A set of pragmatic interventions




Primary Outcome Measures :
  1. Shoulder External Rotation [ Time Frame: 12 months ]
    The change in external rotation range will be assessed at baseline and soon after the application of intervention in each of the trial. A higher score indicate improvement. A digital inclinometer will be used for measurement.

  2. Shoulder Internal Rotation [ Time Frame: 12 months ]
    The change in internal rotation range will be assessed at baseline and soon after the application of in each of the trial.A higher score indicate improvement. A digital inclinometer will be used for measurement.

  3. Shoulder Abduction Range [ Time Frame: 12 months ]
    The change in abduction range will be assessed at baseline and soon after the application of intervention in each of the trial.A higher score indicate improvement. A digital inclinometer will be used for measurement.

  4. Shoulder Flexion [ Time Frame: 12 months ]
    The change in Flexion range will be assessed at baseline and soon after the application of intervention in each trial. A higher score indicate improvement. A digital inclinometer will be used for measurement.

  5. Reaching Up Behind the Back [ Time Frame: 12 months ]
    The change in the distance between tip of the middle finger of one hand and the thumb of the other hand will be measured through measuring tap in each trial, as measured in functional movement screen.A lower difference between the scors indicates improvement.

  6. Reaching Down Behind the Neck [ Time Frame: 12 months ]
    the change in the distance between tip of the middle finger of one hand and the thumb of the other hand will be measured through measuring tap in each trial, as measured in functional movement screen.A lower difference between the scors indicates improvement.

  7. Shoulder pain and Disability Index Urdu version [ Time Frame: 12 months ]
    Change in scores Shoulder pain and disability index Urdu version will be assessed at baseline line in subjects with shoulder pathology and at 6th week of the combined intervention protocol. Less score indicate improved pain and disability


Secondary Outcome Measures :
  1. Subject feed back questions [ Time Frame: 12 months ]
    Suject feedback through a self construct subjective questionaire regarding various aspect of the intervention/interventions will be evaluate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • For trial 1-4

    1. Limitation in Abduction or Internal rotation or reaching behind up or down the back
    2. A score of 1 and 2 on FMS For trial 5
  • main complaint in gleno-humeral joint
  • Limitation in Range of motion of Abduction or internal rotation or external rotation or reaching up behind the back or reaching down behind down the neck , all or only one of the limitation in comparison with the unaffected joint.

Exclusion Criteria:

  • For trial 1-4

    1. Any known pathology or deformity of the shoulder joint
    2. A zero and 3 score on FMS For trial 5
    1. Previous history of dislocation or fracture in shoulder
    2. Severe underlying chronic medical condition
    3. shoulder surgeries
    4. Brachial plexus and axillary nerve injuries
    5. Severe constant shoulder pain which does not fit into the inclusion criteria
    6. Pain associated with shoulder swelling, redness or cysts
    7. Known rheumatoid arthritis
    8. Steroid injection within two weeks
    9. Psychosocial yellow flags or intellectual disability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242888


Contacts
Layout table for location contacts
Contact: Keramat Ullah, M.Phil +923330927670 karamatjee@yahoo.com
Contact: Abdul Hasseb Bhutta, M.Phil 00923335238307 abdulhasseb@hhirs.edu.pk

Locations
Layout table for location information
Pakistan
HHIRS Recruiting
Mansehra, KPK, Pakistan, 21300
Contact: Keramat Ullah, M.Phil    +923330927670    principal@hhirs.edu.pk   
Contact: Abdul Haseeb Bhutta, M.Phil    +923479470947    abdulhaseeb@hhirs.edu.pk   
Sponsors and Collaborators
Isra University
Publications of Results:
Keramat KU, Mc Creesh K, Kropmans T. Voluntary Co-Contraction Exercise Effective In Early Stage Of Subacromial Impingement Syndrome Management. International Journal of Rehabilitation Sciences (IJRS). 2017;4(02):7-13.

Other Publications:

Layout table for additonal information
Responsible Party: Isra University
ClinicalTrials.gov Identifier: NCT04242888    
Other Study ID Numbers: 1602-PhD-001
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be available in two phases. work on the first part in progress and will be shared when available

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases
Shoulder Injuries
Wounds and Injuries