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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06088667
Other study ID # Karabuk University 78
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 15, 2023
Est. completion date July 30, 2024

Study information

Verified date June 2024
Source Karabuk University
Contact Musa Günes, MsC
Phone 05315132482
Email musagunes@karabuk.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Instrument-assisted soft tissue mobilization (IASTM) is a popular treatment method that can be used for myofascial restriction and fascial release. IASTM is used to reduce pain in the area where the pathology is located, increase range of motion (ROM), improve movement function and provide a mobilizing effect. When the literature was examined, no study was found examining the effectiveness of the IASTM technique, which is known to require less effort and stimulate healing compared to manual interventions, in the rehabilitation period after rotator cuff arthroscopic surgery. Therefore, our study aimed to examine the effects of instrument-assisted fascial mobilization given in addition to conventional rehabilitation on long-term pain, function, joint range of motion, fear of movement, and daily living activities in patients who have passed 4 weeks after rotator cuff arthroscopic surgery and are candidates for rehabilitation.


Description:

Rotator cuff (RC) rupture causes shoulder pain, muscle weakness, and decreased shoulder range of motion (ROM). Additionally, fear of movement develops due to shoulder pain, affecting ROM and function. Treatment of RC rupture is initially conservative. In cases where conservative treatment is inadequate, surgical option is preferred. Open, mini-open and arthroscopic repair can be used in surgery. In recent years, arthroscopic repair has been mostly preferred because it causes less pain than other surgical options, has a shorter hospital stay, and does not cause complications. A postoperative rehabilitation program is a crucial component of surgical success. The aim of this program is to reduce pain, increase ROM, and improve patients' functional level and activities of daily living. The postoperative rehabilitation program includes electrophysical agents, manual therapy and exercise.Surgery-related inflammation may restrict fascial tissue. Inflammation changes the mechanical properties of connective tissue, causing adhesions and eventually leading to stiffness. Thus, the slip between fascial surfaces decreases and, accordingly, ROM and function decrease. Instrument Assisted Soft Tissue Mobilization (IASTM) is used for myofascial restriction and fascial release. IASTM is used to reduce pain in the area where the pathology is located, increase range of motion (ROM), improve movement function and provide a mobilizing effect. However, it is noteworthy that there is a lack of studies examining the long-term effectiveness of fascial mobilization in shoulder pathologies. When the literature was examined, no study was found examining the effectiveness of the IASTM technique, which is known to require less effort and stimulate healing compared to manual interventions, in the rehabilitation period after rotator cuff arthroscopic surgery. Therefore, our study aimed to examine the effects of instrument-assisted fascial mobilization given in addition to conventional rehabilitation on long-term pain, function, range of motion, fear of movement, and daily living activities in patients 4 weeks after rotator cuff arthroscopic surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 34
Est. completion date July 30, 2024
Est. primary completion date July 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Age over 18 years old - 4 weeks have passed since arthroscopic rotator cuff repair Exclusion Criteria: - cervical discopathy, - shoulder osteoarthritis - fracture or tumor of the upper extremity, - adhesive capsulitis, - shoulder instability, - thoracic outlet syndrome and - patients with neurological or mental problems. - Non-voluntary patients

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Fascial mobilization group
In addition to the rehabilitation given to the control group, the fascial release group will be treated with the Graston device to the superficial and deep fascia of the neck and shoulder muscles, biceps and triceps brachii muscles and forearm compartments for 4 weeks.

Locations

Country Name City State
Turkey Karabuk University, Physiotherapy and Rehabilitation Application and Research Center Karabük

Sponsors (1)

Lead Sponsor Collaborator
Karabuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Coban T, Demirdel E, Yildirim NU, Deveci A. The investigation of acute effects of fascial release technique in patients with arthroscopic rotator cuff repair: A randomized controlled trial. Complement Ther Clin Pract. 2022 Aug;48:101573. doi: 10.1016/j.ct — View Citation

Nikolaidou O, Migkou S, Karampalis C. Rehabilitation after Rotator Cuff Repair. Open Orthop J. 2017 Feb 28;11:154-162. doi: 10.2174/1874325001711010154. eCollection 2017. — View Citation

Pegreffi F, Paladini P, Campi F, Porcellini G. Conservative management of rotator cuff tear. Sports Med Arthrosc Rev. 2011 Dec;19(4):348-53. doi: 10.1097/JSA.0b013e3182148dc6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain severity Visuel analog scale will be used to evaluate individuals' shoulder pain level. baseline and 4 weeks post-intervention
Secondary Range of motion Joint range of motion will be assessed using a universal goniometer baseline and 4 weeks post-intervention
Secondary Kinesiophobia The Tampa Kinesiophobia Scale (TSK) will be used to measure individuals' fear of movement/reinjury. baseline and 4 weeks post-intervention
Secondary Functional level The Shoulder Pain and Disability Index (SPADI) will be used to evaluate functional disability. baseline and 4 weeks post-intervention
Secondary Activities of Daily Living The Disabilities of the Arm, Shoulder and Hand Scale will be used to evaluate acitivities of daily living. baseline and 4 weeks post-intervention
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