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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03735485
Other study ID # SevgiMC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 3, 2017
Est. completion date January 10, 2018

Study information

Verified date November 2018
Source Sevgi Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim of the study was to compare the effectiveness of Proprioceptive Neuromuscular Facilitation (PNF) exercises and Shoulder Mobilization (SM) on pain, range of motion (ROM), functionality, and muscle strength in patients with Subacromial Impingement Syndrome (SIS). Patients received 20 sessions (for 4 weeks) under the supervision of a physiotherapist. Patients were evaluated at baseline, at week two, at week four, and at week sixteen.


Description:

Aim of the study was to compare the effectiveness of Proprioceptive Neuromuscular Facilitation (PNF) exercises and Shoulder Mobilization (SM) on pain, range of motion (ROM), functionality, and muscle strength in patients with Subacromial Impingement Syndrome (SIS). Forty-four patients were divided into three groups as Group I: Conventional physiotherapy receiving group (control group; n=14), Group II: Conventional physiotherapy + PNF exercises receiving group (PNF group; n=15), and Group III: conventional physiotherapy + SM receiving group (SM group; n=15). Pain, ROM, muscle strength, and functionality were evaluated by using visual analog scale (VAS), goniometer, push-pull dynamometer, Constant-Murley score and The Disabilities of the Arm, Shoulder and Hand (DASH) Score respectively. Patients received 20 sessions in total under supervision of a physiotherapist. Patients were evaluated at baseline, at week two, at week four, and at week sixteen.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date January 10, 2018
Est. primary completion date October 2, 2017
Accepts healthy volunteers No
Gender All
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria:

- Aged between 25-65 years old,

- Having the diagnosis of Subacromial Impingement Syndrome (SIS),

- Having shoulder pain at least for four weeks

Exclusion Criteria:

- Having a neuromuscular disease,

- Pregnancy,

- History of cancer,

- Unstable angina,

- Having pulmonary and/or vascular problems,

- History of surgery at neck, shoulder, elbow or/and hand,

- Having communication problems

- Having systemic anti-inflammatory joint diseases

- Being contraindicated for electrical stimulation and/or exercise

- Having cervical disc herniation or radiculopathy

- History of physiotherapy on the same shoulder due to SIS,

- A history of corticosteroid injection in the last three months,

- Any orthopedic, rheumatologic, or congenital condition that effects the targeted shoulder

Study Design


Intervention

Other:
Conventional Physiotherapy
The conventional physiotherapy program consisted of electrotherapy and exercise approaches. The electrotherapy program consisted of infrared (for 15 minutes, from 70 cm distance), conventional Transcutaneous Electrical Nerve Stimulation (TENS) in an encircled region (for 20 minutes; with 4 electrodes, 100 Hz, 100 msec), and therapeutic Ultrasound (for 3 minutes; 1 megahertz (MHz), power: 1,5 W/cm²). A physiotherapist supervised exercise program was performed following the electrotherapy program. Elastic resistive exercises were added at the week three. While, the first set of wand exercises and elastic resistive exercises was performed under supervision, two sets of the showed exercises were given as the home exercise program.
Shoulder Mobilization
In shoulder mobilization technique while the shoulder joint was placed in the traction, anterior, posterior, and inferior gliding and circumduction were applied to the humerus for 2-3 minutes. All mobilization applications were performed in painless range of motion (ROM) limits. The degree of traction and gliding were increased as the relaxing obtained in the tissues.
Proprioceptive Neuromuscular Facilitation
In the Proprioceptive Neuromuscular Facilitation (PNF) program participants received PNF exercises with contract-relax technique, in the patterns of "flexion-abduction-external rotation", "extension-adduction-internal rotation", "flexion-adduction-external rotation" and "extension-abduction-internal rotation" along with the verbal and manual facilitation of the physiotherapist.

Locations

Country Name City State
Turkey Sevgi Medical Center Istanbul Arnavutkoy

Sponsors (1)

Lead Sponsor Collaborator
Sevgi Medical Center

Country where clinical trial is conducted

Turkey, 

References & Publications (21)

Andrews AW, Thomas MW, Bohannon RW. Normative values for isometric muscle force measurements obtained with hand-held dynamometers. Phys Ther. 1996 Mar;76(3):248-59. — View Citation

Aytar A, Baltaci G, Uhl TL, Tuzun H, Oztop P, Karatas M. The effects of scapular mobilization in patients with subacromial impingement syndrome: a randomized, double-blind, placebo-controlled clinical trial. J Sport Rehabil. 2015 May;24(2):116-29. doi: 10.1123/jsr.2013-0120. Epub 2014 Jul 23. — View Citation

Bandholm T, Rasmussen L, Aagaard P, Jensen BR, Diederichsen L. Force steadiness, muscle activity, and maximal muscle strength in subjects with subacromial impingement syndrome. Muscle Nerve. 2006 Nov;34(5):631-9. — View Citation

Bang MD, Deyle GD. Comparison of supervised exercise with and without manual physical therapy for patients with shoulder impingement syndrome. J Orthop Sports Phys Ther. 2000 Mar;30(3):126-37. — View Citation

Bennell K, Wee E, Coburn S, Green S, Harris A, Staples M, Forbes A, Buchbinder R. Efficacy of standardised manual therapy and home exercise programme for chronic rotator cuff disease: randomised placebo controlled trial. BMJ. 2010 Jun 8;340:c2756. doi: 10.1136/bmj.c2756. — View Citation

Bicer A, Ankarali H. Shoulder pain and disability index: a validation study in Turkish women. Singapore Med J. 2010 Nov;51(11):865-70. — View Citation

Cardoso de Souza M, Trajano Jorge R, Jones A, Lombardi Júnior I, Natour J. Progressive resistance training in patients with shoulder impingement syndrome: literature review. Reumatismo. 2009 Apr-Jun;61(2):84-9. Review. — View Citation

Celik D, Atalar AC, Sahinkaya S, Demirhan M. [The value of intermittent ultrasound treatment in subacromial impingement syndrome]. Acta Orthop Traumatol Turc. 2009 May-Jul;43(3):243-7. doi: 10.3944/AOTT.2009.243. Turkish. — View Citation

Çelik D. Turkish version of the modified Constant-Murley score and standardized test protocol: reliability and validity. Acta Orthop Traumatol Turc. 2016;50(1):69-75. doi: 10.3944/AOTT.2016.14.0354. — View Citation

de Witte PB, Nagels J, van Arkel ER, Visser CP, Nelissen RG, de Groot JH. Study protocol subacromial impingement syndrome: the identification of pathophysiologic mechanisms (SISTIM). BMC Musculoskelet Disord. 2011 Dec 14;12:282. doi: 10.1186/1471-2474-12-282. — View Citation

Delgado-Gil JA, Prado-Robles E, Rodrigues-de-Souza DP, Cleland JA, Fernández-de-las-Peñas C, Alburquerque-Sendín F. Effects of mobilization with movement on pain and range of motion in patients with unilateral shoulder impingement syndrome: a randomized controlled trial. J Manipulative Physiol Ther. 2015 May;38(4):245-52. doi: 10.1016/j.jmpt.2014.12.008. Epub 2015 Apr 30. — View Citation

Haik MN, Alburquerque-Sendín F, Moreira RF, Pires ED, Camargo PR. Effectiveness of physical therapy treatment of clearly defined subacromial pain: a systematic review of randomised controlled trials. Br J Sports Med. 2016 Sep;50(18):1124-34. doi: 10.1136/bjsports-2015-095771. Epub 2016 Jun 10. Review. — View Citation

Kim JJ, Lee SY, Ha K. The effects of exercise using PNF in patients with a supraspinatus muscle tear. J Phys Ther Sci. 2015 Aug;27(8):2443-6. doi: 10.1589/jpts.27.2443. Epub 2015 Aug 21. — View Citation

Lazaro R. Shoulder impingement syndromes: implications on physical therapy examination and intervention. J Jpn Phys Ther Assoc. 2005;8(1):1-7. doi: 10.1298/jjpta.8.1. Review. — View Citation

Lombardi I Jr, Magri AG, Fleury AM, Da Silva AC, Natour J. Progressive resistance training in patients with shoulder impingement syndrome: a randomized controlled trial. Arthritis Rheum. 2008 May 15;59(5):615-22. doi: 10.1002/art.23576. — View Citation

Michener LA, McClure PW, Karduna AR. Anatomical and biomechanical mechanisms of subacromial impingement syndrome. Clin Biomech (Bristol, Avon). 2003 Jun;18(5):369-79. Review. — View Citation

Millar AL, Lasheway PA, Eaton W, Christensen F. A retrospective, descriptive study of shoulder outcomes in outpatient physical therapy. J Orthop Sports Phys Ther. 2006 Jun;36(6):403-14. — View Citation

Oledzka M, Jaczewska-Bogacka J. Effectiveness of Proprioceptive Neuromuscular Facilitation (PNF) in Improving Shoulder Range of Motion. A Pilot Study. Ortop Traumatol Rehabil. 2017 May 10;19(3):285-292. — View Citation

Pappas AM, Zawacki RM, McCarthy CF. Rehabilitation of the pitching shoulder. Am J Sports Med. 1985 Jul-Aug;13(4):223-35. — View Citation

Senbursa G, Baltaci G, Atay A. Comparison of conservative treatment with and without manual physical therapy for patients with shoulder impingement syndrome: a prospective, randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2007 Jul;15(7):915-21. Epub 2007 Feb 28. — View Citation

Warner JJ, Micheli LJ, Arslanian LE, Kennedy J, Kennedy R. Patterns of flexibility, laxity, and strength in normal shoulders and shoulders with instability and impingement. Am J Sports Med. 1990 Jul-Aug;18(4):366-75. — View Citation

* Note: There are 21 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Shoulder pain: VAS Pain was defined with Visual Analog Scale (VAS). A 10-cm long horizontal visual analog scale (VAS) with marks 0 point (no pain) and 10 point (unbearable pain) was used for evaluating the pain severity. The patients were asked to mark the representing point of their pain levels. The values were recorded in cm. The pain severity was asked in three occasions as: at resting (VASr), during activity (VASa) and during night (VASn). Change from baseline pain scale of shoulder at week 2, 4 and 16.
Primary Disability of the shoulder The Disabilities of the Arm, Shoulder and Hand (DASH) Score was used to evaluate the upper extremity physical function. DASH includes two modules as disability / symptom section and work section. The scores are ranged between 0-100. Higher scores indicate lower functionality. Change from baseline Disabilities of the Arm, Shoulder and Hand (DASH) Score at week 2, 4 and 16.
Primary Function of the shoulder In addition to DASH, the Constant-Murley score was used to evaluate the functionality of the shoulder. Constant-Murley score is a 100-point scoring system and consisted of four sub-scores as pain (15 points), daily living activities (20 points), active range of motion (40 points), and muscle strength (25 points). Change from baseline Constant-Murley score at week 2, 4 and 16.
Primary Range of motion The active range of motion was assessed by using a universal goniometer. Change from baseline active range of motion at week 2, 4 and 16.
Primary Muscle Strength The muscle strength of shoulder flexion, shoulder abduction, shoulder adduction, shoulder external rotation, and shoulder internal rotation were determined by using Baseline Push-Pull (New York, USA) dynamometer. The dynamometer was placed in a 90 degrees angle on the location and the patient was asked to contract in maximum for two seconds and then maintain this position for five seconds. Two assessments were performed, and average values were recorded. Pain was avoided during the measurements. Change from baseline muscle strength of shoulder flexion, shoulder abduction, shoulder adduction, shoulder external rotation, and shoulder internal rotation at week 2, 4 and 16.
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