Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03791892
Other study ID # RiphahI Wajeeha
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2018
Est. completion date April 30, 2019

Study information

Verified date May 2019
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date April 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Shoulder mobilization Group
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)
Conventional Treatment 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)

Locations

Country Name City State
Pakistan Imran Amjad Islamabad Punjab
Pakistan Riphah International University Islamabad

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

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. Epub 2006 Oct 10. Erratum in: Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):687. — View 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. Review. — View Citation

Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. Review. — View 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. Review. — View 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. Review. — View Citation

Siegel LB, Cohen NJ, Gall EP. Adhesive capsulitis: a sticky issue. Am Fam Physician. 1999 Apr 1;59(7):1843-52. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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 change from baseline.This tool is used to measure shoulder disability
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03245476 - Education-based Physical Therapy Approach for Adhesive Capsulitis N/A
Recruiting NCT03462420 - Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes N/A
Recruiting NCT06181461 - Gong's Versus Kaltenborn Mobilization on Pain, Range of Motion and Function in Adhesive Capsulitis N/A
Completed NCT03678038 - Comparison of Rotator Interval Injection Versus Intraarticular Hydrodilatation in Frozen Shoulder N/A
Completed NCT01458691 - Intra-articular Injection of Allogeneic Platelet Rich Plasma (PRP) for Adhesive Capsulitis N/A
Recruiting NCT01449227 - Natural Course of Adhesive Capsulitis of Hip N/A
Terminated NCT00875862 - Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks Phase 4
Completed NCT05398588 - Spencer's Muscle Energy Technique and Cyriax Deep Friction Massage on Adhesive Capsulitis N/A
Completed NCT05402540 - Effectiveness of SCS Technique Verses ART in Adhesive Capsulitis N/A
Recruiting NCT03676829 - Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis Phase 1/Phase 2
Active, not recruiting NCT06404814 - Effectiveness of Functional Electrical Stimulation Versus Spencer Technique in Patients With Adhesive Capsulitis N/A
Completed NCT06019780 - Effects of Blood Flow Restriction Training in Patients With Adhesive Capsulitis N/A
Completed NCT06062654 - Ultrasound-guided Hydrodistension in Patients With Adhesive Capsulitis N/A
Completed NCT05897866 - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) N/A
Completed NCT04822324 - Spencer's Muscle Energy Technique Along With Strain Counter Strain in Adhesive Capsulitis. N/A
Recruiting NCT06041282 - Conservative Treatment of Early Adhesive Capsulitis N/A
Withdrawn NCT03770546 - Amnion-Based Injections in the Shoulder N/A
Completed NCT06064396 - Effects of Gong's Mobilization With and Without Stecco Fascial Therapy in Patients With Adhesive Capsulitis N/A
Completed NCT04852939 - Bowen's Technique in Patients With Adhesive Capsulitis N/A
Completed NCT05655611 - Muscle Energy Technique With Or Without First Rib Mobilization In Adhesive Capsulitis N/A