Comparison of Two Different Treatment Methods

Sponsor
Banu BAYAR (Other)
Overall Status
Completed
CT.gov ID
NCT05071469
Collaborator
Muğla Sıtkı Koçman University (Other)
60
1
3
2.1
29

Study Details

Study Description

Brief Summary

A number of previous studies investigated the effects of kinesiotaping (KT) in subacromial impingement syndrome (SIS). In recent studies, KT has been used for SIS to obtain an early effect on decreasing pain and improved functioning. The efficacy of KT and physical therapy modalities have been compared in patients with SIS and recommended KT as a treatment alternative, especially when an immediate effect was desired. In similarly there are some studies demonstrating that Mulligan Mobilization Technique (MMT) is effective in various shoulder pathologies included SIS. According to our knowledge, there was no study in the literature that compares the short-term effects of these two techniques on SIS. Therefore, the aim of the present study is to investigate and compare the short-term effects of MMT and KT on shoulder pain, limitation, disability and life satisfaction in patients with SIS.

Condition or Disease Intervention/Treatment Phase
  • Other: Kinesiotaping
  • Other: Mulligan Mobilization Technique
N/A

Detailed Description

Subacromial impingement syndrome (SIS) is characterized by shoulder pain that is exacerbated with especially arm elevation or overhead physical activities. Epidemiological studies have shown that the rate of shoulder problems in the general population ranges from 6% to 14%. SIS constitutes 44-65% of all shoulder complaints. The etiology of SIS has number of factors. Two primary contributing factors are narrowing of the subacromial space and enlargement of the subacromial soft tissues such as bursae or tendons. SIS is defined as the mechanical pressure of the rotator cuff, especially the supraspinatus tendon or the subacromial bursa in the subacromial space between the humeral head and the acromion or coracohumeral ligament.

Treatment can be classified into conservative and surgical methods. The conservative treatment options for SIS include rest, ice, physiotherapy, ultrasonic therapies, transcutaneous electrical nerve stimulation therapy, oral medications, subacromial injections, shock wave treatment, acupuncture. The surgical approach that objectives at decompression of the subacromial space are mostly done arthroscopically. A combination of non-steroidal anti-inflammatory drugs and rehabilitation is the most proven treatment modality. Rehabilitation protocols for SIS are including stretching, strengthening exercises, and sometimes manual therapy for soft tissues surrounding the shoulder complex.

The Mulligan Mobilization Technique (MMT) is a type of joint mobilization developed by Brain Mulligan who is a physiotherapist from New Zealand, and the main purpose of this treatment is to correct joint biomechanics. The basis of Mulligan's theory is the positional error that develops secondary, causing incorrect displacement of the joint. The positional error can occur as a result of deterioration of the surface of the joints, thinning of the cartilage, and incompatibility in the ligaments and capsules. This technique was found by regulating the Kaltenborn principles from the physiological joint motion component. The MMT is a treatment method based on precise principles such as passive slipping that does not cause pain or symptoms and providing normal movement and function restoration of joints and surrounding soft tissues.

Kinesiotaping method (KT), developed by Dr. Kenso Kase who is a chiropractor, has been widely used also for various musculoskeletal disorders including shoulder problems. Kinesiotape is an elastic adhesive band that has the stretching ability to provide mobility of the performed area of the body. KT has several effects such as reduce pain, muscle spasms, support weakened muscles, improve soft tissues, ensure correct alignment, and enhance local blood circulation. The KT applying method includes some properties such as percent of tension, applied tissue, and applied directly. The effects of KT have also changed to depends on applying method.

A number of previous studies investigated the effects of KT in SIS. In recent studies, KT has been used for SIS to obtain early effect on decreasing pain and improved functioning. The efficacy of KT and physical therapy modalities have been compared in patients with SIS and recommended KT as a treatment alternative, especially when an immediate effect was desired. In similarly there are some studies demonstrating that MMT is effective in various shoulder pathologies included SIS. According to our knowledge, there was no study in the literature that compares the short-term effects of these two techniques on SIS. Therefore, the aim of the present study is to investigate and compare the short-term effects of MMT and KT on shoulder pain, limitation, disability and life satisfaction in patients with SIS.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled TrialRandomized Controlled Trial
Masking:
Single (Outcomes Assessor)
Masking Description:
Single
Primary Purpose:
Treatment
Official Title:
Comparison of Short-term Effects of Two Different Treatment Methods in Patients With Subacromial Impingement Syndrome: a Randomized Controlled Single-blind Trial
Actual Study Start Date :
Sep 28, 2021
Actual Primary Completion Date :
Oct 15, 2021
Actual Study Completion Date :
Nov 30, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Group (CG)

Patients in the control group which waiting an appointment for the physiotherapy program received no intervention.

Experimental: Kinesiotaping Group (KG)

The first strip was a Y-strip for inhibition of the supraspinatus and was applied from its insertion to origo with paper-off tension. This strip was applied with the patient in a position of combining contra-lateral cervical side bending and the arm reaching behind the back. The second strip was an I-strip with Y shape at the end of tape. It was applied from the coracoid process around the posterior deltoid with approximately 50% to 75% tension and downward pressure applied for a mechanical correction.

Other: Kinesiotaping
Patients were instructed to keep the tape on for 72 hours and then to remove it and to come back to the clinic for second intervention. KT repeated every four days, twice times in two weeks. Two strips were used for KT procedure. The first strip was a Y-strip for inhibition of the supraspinatus and was applied from its insertion to origo with paper-off tension. This strip was applied with the patient in a position of combining contra-lateral cervical side bending and the arm reaching behind the back. The second strip was an I-strip with Y shape at the end of tape. It was applied from the coracoid process around the posterior deltoid with approximately 50% to 75% tension and downward pressure applied for a mechanical correction. For this technique, the shoulder was externally rotated while at the side and then moved into flexion and slight horizontal adduction as the end of the tape was applied with no stretch.

Experimental: Mulligan Mobilization Technique Group (MG)

The physiotherapist glided the humeral head in a postero-lateral-inferior direction with thenar eminence. The patient performed the offending movement while the glide was sustained. This movement should now become pain-free. Passive overpressure could be given by the patient at the end of the newly available range using his/her other hand. The hand of the physiotherapist should also move along with the movement in order to sustain the glide along the treatment plane. When the patient moved his/her shoulder, rotation of the scapula allowed upward. MT was applied 10 repetitions for each session, 30 sec rest period between sets, 4 sessions with 24 hours between 2 treatment seasons.

Other: Mulligan Mobilization Technique
The patient performed the offending movement while the glide was sustained. This movement should now become pain-free. Passive overpressure could be given by the patient at the end of the newly available range using his/her other hand. The hand of the physiotherapist should also move along with the movement in order to sustain the glide along the treatment plane. When the patient moved his/her shoulder, rotation of the scapula allowed upward. MT was applied 10 repetitions for each session, 30 sec rest period between sets, 4 sessions with 24 hours between 2 treatment seasons.

Outcome Measures

Primary Outcome Measures

  1. Change of pain severity [Baseline- after 2 weeks (after treatment)]

    Visual Analogue Scale (VAS) was used to evaluate the pain.

  2. Change of Range of Motion [Baseline- after 2 weeks (after treatment)]

    The most limited movements of shoulder flexion and abduction in the SIS of the patients included in the study were measured using a universal goniometer.

  3. Change of Functionality [Baseline- after 2 weeks (after treatment)]

    The severity of pain during certain activities and the limitations were evaluated using the Shoulder Pain and Disability Index (SPADI).

Secondary Outcome Measures

  1. Change of Sleep Quality [Baseline- after 2 weeks (after treatment)]

    The level of pain affecting sleep due to shoulder problems in patients was questioned by VAS.

  2. Change of Satisfaction of Life [Baseline- after 2 weeks (after treatment)]

    The Satisfaction with Life Scale (SWLS) was to evaluate the expectations and attitudes of the patients and their perspectives on their own life.

  3. Change of Satisfaction of Treatment [Baseline- after 2 weeks (after treatment)]

    VAS was used to evaluate the treatment satisfaction of patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Have impingement symptoms in clinical tests (Neer impingement test, Hawkin sign, Jobe supraspinatus test) for the last 1 to 6 months with the unilateral shoulder.

  • Have shoulder pain for at least 1 month.

Exclusion Criteria:
  • Diagnosed any shoulder pathology other than SIS.

  • Have chronic systemic diseases or infections.

  • History of surgery, malignancy, brachial plexus lesion, peripheral neuropaty, humerus fracture, traumatic onset, the existence of massive rotator cuff tears, long head of biceps tendon tears, degenerative and inflammatory joint disorders at the shoulder complex.

  • Receiving steroid injections and therapeutic approaches for SIS during the last six months before the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Muğla Sıtkı Koçman University Muğla Turkey 48000

Sponsors and Collaborators

  • Banu BAYAR
  • Muğla Sıtkı Koçman University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Banu BAYAR, Principal investigator, Head of Physiotherapy and Rehabilitation Department, Pt. PhD. Prof., Muğla Sıtkı Koçman University
ClinicalTrials.gov Identifier:
NCT05071469
Other Study ID Numbers:
  • 180030/16
First Posted:
Oct 8, 2021
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Banu BAYAR, Principal investigator, Head of Physiotherapy and Rehabilitation Department, Pt. PhD. Prof., Muğla Sıtkı Koçman University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022