Effects of Cold and Kinesio Taping in Individuals With Rotator Cuff Tendonitis

NCT06425913 | Completed

• 1 other identifier: 71306642
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Rotator cuff tendonitis (RCT) is one of the most common shoulder pathologies, causing pain, limitation of shoulder joint movements, and impaired function. Patient education, medical treatment, corticosteroid injections, physiotherapy rehabilitation approaches are the most common treatment options applied to alleviate the symptoms of RCT. Despite these various treatment methods, there are currently no specific guidelines regarding the most appropriate and effective intervention for RCT treatment. This is mainly because adequate, high-quality studies are lacking in RCT management. To the best of our knowledge, no studies have evaluated the effects of Kinesio Taping (KT), which has become a popular approach in recent years, and Cold Therapy (CT), which has often been used as a therapeutic agent since immemorial, on individuals with RCT. In this regard, this study aimed to investigate and compare the short-term effects of KT and CT on pain and upper extremity functionality in individuals with RCT.

Conditions

Rotator Cuff Tendinitis

Outcome Measures

Primary Outcomes (3)

• Pain intensity

  Numerical Rating Scale (NRS): The pain severity was assessed using the NRS, for which a subject was asked to rate his/her perceived pain. A 11-point NRS from 0 to 10 which 0 means no pain and 10 means the worst possible pain was scored during night, rest, and activity.

  At baseline and after three days of the applications

• Function

  Disability of the Arm, Shoulder and Hand (DASH) Questionnaire): DASH is a self-reported questionnaire designed for evaluating the functional level of upper extremity. It is a 30-item scale that addresses difficulty in performing various physical activities that require upper extremity function (physical function, 21 items); symptoms of pain, activity-related pain, tingling, weakness, and stiffness (pain symptoms, 5 items); or impact of disability and symptoms on social activities, work, sleep, and psychological well-being (emotional and social function, 4 items). Each item is scored between 1 and 5. A score of 1 indicates no strain, and a score of 5 indicates inability to perform the specified activity.

  At baseline and after three days of the applications

• Function

  Shoulder Pain and Disability Index (SPADI): The SPADI is a self-administered questionnaire developed to measure the pain and disability associated with shoulder pathology in people with shoulder pain of musculoskeletal, neurogenic, or undetermined origin. It consists of 13 items that assess two domains: a 5-item subscale that measures pain and an 8-item subscale that measures disability. The items of both domains were scored on a numerical rating scale ranging from 0 to 10, where 0=no pain/no disability and 10= worst pain imaginable/so difficult required help.

  At baseline and after three days of the applications

Secondary Outcomes (2)

• Range of Motion

  At baseline and after three days of the applications

• Grip strength

  At baseline and after three days of the applications

Study Arms (2)

Kinesio Taping

ACTIVE COMPARATOR

KT was applied to the symptomatic shoulder of participants.

Other: Kinesio Taping (KT); Other: standardized home exercise program

Cold Therapy

ACTIVE COMPARATOR

Ice packs were applied to the symptomatic shoulder of participants.

Other: Cold Therapy (CT); Other: standardized home exercise program

Interventions

Kinesio Taping (KT) OTHER

KT was applied to the symptomatic shoulder at the end of the baseline assessment by a certificated physiotherapist with over ten years of experience in Kinesio taping. After three days, participants were re-evaluated. KT application has been made according to the protocol for rotator cuff impingement or tendonitis including inhibition and correction techniques.

Kinesio Taping

Cold Therapy (CT) OTHER

The initial application was administered by the physiotherapist. In a sitting position, a pack was wrapped in a thin towel and placed on the affected shoulder joint, including the painful locations. During the application, the participant was closely observed for discomfort or adverse reactions (redness, burning, numbness, itching, …). The cold application was continued for 20 minutes.After the first application, participants were instructed to apply ice for 20 minutes five times a day for three days at home or work.

Cold Therapy

standardized home exercise program OTHER

All participants performed standardized home exercise program, including shoulder isometric and stretching exercises were . A physiotherapist taught the exercise program until the participants were able to exercise accurately on their own. All participants were instructed to perform the exercises three times a day for three days.

Cold Therapy; Kinesio Taping

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• RCT diagnosis
• Excluding other shoulder pathologies by magnetic resonance imaging (MRI) and specific tests

You may not qualify if:

• Glenohumeral joint dislocation/subluxation;
• Acromioclavicular sprain;
• Rotator cuff tear;
• Glenohumeral joint instability;
• Calcific tendinitis of the shoulder;
• Acromioclavicular joint pathologies,
• Hyperlaxity;
• Any fracture in the shoulder;
• Diabetes, thyroid and any vascular or rheumatologic disease;
• Glenohumeral joint deformities;
• Superior labrum anteroposterior (SLAP) lesion;
• Shoulder pain lasting more than six months;
• History of shoulder surgery;
• Intra-articular steroid injection

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University

Istanbul, 34060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants were unaware of their group assignments. A therapist who was unaware of the intervention protocol and assigned groups performed the assessment procedures
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 23, 2024
• Study Start: June 1, 2021
• Primary Completion: February 26, 2023
• Study Completion: February 28, 2023
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)