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Shoulder Mobilization Following Supra Scapular Nerve Block in Adhesive Capsulitis

Primary Purpose

Adhesive Capsulitis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Shoulder mobilization Group
Conventional Treatment Group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adhesive Capsulitis focused on measuring Adhesive capsulitis, suprascapular nerve, shoulder mobilization

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Imran Amjad
  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Shoulder mobilization Group

Conventional treatment Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

SHOULDER PAIN AND DISABILITY INDEX (SPADI)
By using this tool we can access pain as well as level of disability of patient having frozen shoulder. This tool consists of 13 questions. A therapist asked questions to patients. It takes 5 to 10 minutes to finish the questionnaire n marked accordingly. SPADI values were taken at baseline, 7th visit and post visit

Full Information

First Posted
December 31, 2018
Last Updated
May 15, 2019
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT03791892
Brief Title
Shoulder Mobilization Following Supra Scapular Nerve Block in Adhesive Capsulitis
Official Title
The Effects of Shoulder Mobilization Following Supra Scapular Nerve Block in Adhesive
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 15, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Adhesive capsulitis is one of the most common debilitating musculoskeletal complaints seen in physiotherapy practice. Adhesive capsulitis is a benign, self-limiting condition of unknown etiology characterized by painful and limited active and passive gleno-humeral range of motion of ≥ 25% in at least two directions most notably shoulder abduction and external rotation. Prevalence of adhesive capsulitis is 2% - 5% in general population.1 Primary adhesive capsulitis and frozen shoulder are current terms used to describe an insidious onset of painful stiffness of the gleno-humeral joint. Secondary adhesive capsulitis, on the other hand, is associated with a known predisposing condition of the shoulder (eg, humerus fracture, shoulder dislocation, avascular necrosis, osteoarthritis, or stroke. The range of motion (ROM) impairments associated with primary adhesive capsulitis can impact a patient's ability to participate in self-care and occupational activities. Even though this condition is considered self-limiting, with most patients having spontaneous resolution within 3 years, some patients can suffer long-term pain and restricted shoulder motion well beyond 3 years. A disability of this duration places severe emotional and economic hardship on the afflicted person. Most patients are unwilling to suffer this pain, prolonged disability, and sleep deprivation without seeking treatment. Currently, no standard medical, surgical, or therapy regimen is universally accepted as the most efficacious treatment for restoring motion in patients with shoulder adhesive capsulitis. While physical therapy is commonly prescribed for this condition, some studies have found little treatment benefit. Rehabilitation programs consisting of exercise, massage, and modalities have been shown to improve shoulder ROM in all planes except external and internal rotation. There is evidence, however, that joint mobilization procedures can lessen the associated gleno-humeral rotational deficits characteristic of this condition, especially external rotation. The optimal direction of force and movement application for the joint mobilization to restore external rotation, however, is not clear. Traditionally, physical therapists have used an anterior glide of the humeral head on the glenoid technique to improve external rotation ROM, a choice based on the "convex-on-concave" concept of joint surface motion. In contrast, Roubal et al used a posteriorly directed glide manipulation based on the "capsular constraint mechanism" to restore external as well as internal rotation ROM.Supra-scapular nerve block (SSNB) is a safe and effective method to treat pain in chronic diseases that affect the shoulder. The technique consists of injecting anaesthetics in supraspinatus fossa of affected shoulder, with the patient sitting down and upper limbs pending beside the body.The technique consists of injecting anesthetic in supraspinatus fossa of affected shoulder, with the patient sitting down and upper limbs pending beside the body.3 In this study keltenborn joint mobilization will be use as intervention is to restore the joint play and in order to normalize the rolling and gliding of any joint, which are necessary for the active normal and non-painful movement. Some general exercises also help us to treat adhesive capsulitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Adhesive capsulitis, suprascapular nerve, shoulder mobilization

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shoulder mobilization Group
Arm Type
Experimental
Arm Description
Kaltenborn mobilization will be applied to patient in experimental group only.
Arm Title
Conventional treatment Group
Arm Type
Active Comparator
Arm Description
Application of conventional treatment that includes stretching and strengthening exercises of shoulder.
Intervention Type
Other
Intervention Name(s)
Shoulder mobilization Group
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Conventional Treatment Group
Intervention Description
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)
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
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
Time Frame
change from baseline.This tool is used to measure pain intensity
Title
Goniometer
Description
In physical therapy goniometer is utilized to measures range of movement joint angles in the body.
Time Frame
change from baseline.This tool is used to measure shoulder ranges
Secondary Outcome Measure Information:
Title
SHOULDER PAIN AND DISABILITY INDEX (SPADI)
Description
By using this tool we can access pain as well as level of disability of patient having frozen shoulder. This tool consists of 13 questions. A therapist asked questions to patients. It takes 5 to 10 minutes to finish the questionnaire n marked accordingly. SPADI values were taken at baseline, 7th visit and post visit
Time Frame
change from baseline.This tool is used to measure shoulder disability

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 40 to 70 years Both male and female Unilateral cases. Grade 1 and 2 phase of adhesive shoulder Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
imran Amjad, phd*
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imran Amjad
City
Islamabad
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
Facility Name
Riphah International University
City
Islamabad
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18475240
Citation
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.
Results Reference
background
PubMed Identifier
16282408
Citation
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.
Results Reference
background
PubMed Identifier
29992159
Citation
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.
Results Reference
background
PubMed Identifier
20110457
Citation
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.
Results Reference
background
PubMed Identifier
10208704
Citation
Siegel LB, Cohen NJ, Gall EP. Adhesive capsulitis: a sticky issue. Am Fam Physician. 1999 Apr 1;59(7):1843-52.
Results Reference
background
PubMed Identifier
16356983
Citation
Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.
Results Reference
background
PubMed Identifier
17031613
Citation
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. Erratum In: Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):687.
Results Reference
background

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Shoulder Mobilization Following Supra Scapular Nerve Block in Adhesive Capsulitis

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