The Effect of Progressive Muscle Relaxation Exercises on Pain and Disability After Spinal Surgery

November 27, 2023 updated by: Eda Polat, Istanbul Medeniyet University
This study was planned as a randomized controlled experimental study to determine the effect of progressive muscle relaxation exercises on pain and disability in patients undergoing spinal surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Low back pain is not a disease in itself, but a symptom with many causes. The term "low back pain" means pain felt close to the midline of the lumbar or sacral region. It is a common problem in the society that causes loss of workforce and is accepted as a common cause of disability (functional limitation). Vertebral compression fractures, degenerative joint disease, spinal stenosis and various mechanical disorders are among the causes of low back pain. Although due to other pathologies, the general opinion is that lumbar disc prolapses often suppress or irritate one or more nerve roots in the lumbosacral region, causing pain that radiates to certain areas of the hips or legs. This pain is defined as lumbosacral radiculopathy. Although lumbosacral radiculopathy is treated conservatively in many patients, surgery is a common option in patients with persistent symptoms. The aim of surgical treatment methods such as discectomy, laminectomy, foraminotomy and spinal fusion is to release the neural structures by removing the herniated disc that compresses the nerve root and dura. Although there are various outcomes to measure the success of treatment after lumbar disc surgery, reduction of pain and returning to normal activities remain the main goals for patients. In the studies performed, it was determined that almost every patient had low back and leg pain, low quality of life scores and high disability scores before the surgery, while it was determined that there was an improvement in pain and other areas after the surgery. However, in the literature, complete relief after surgery is rarely seen, and symptoms persist in patients; It is stated that the severity varies from minor and non-irritating to severe and debilitating. Persistent and recurrent radicular pain after lumbar surgery is often associated with compression of the nerve roots. Zanoli et al. (2001) found that after surgical interventions for degenerative lumbar spine diseases, tolerable pain continued in the same way or increased in the 4th and 12th months postoperatively. Häkkinen et al. (2004) found that although there was improvement in postoperative back and leg pain, 25% of the patients still had moderate or severe leg pain at the 2nd month postoperatively, and approximately 30% perceived moderate or severe disability. Similarly, Lee et al. (2017) also found that although there was an improvement in the level of pain after surgery, the pain continued at a moderate level in the 3rd, 6th and 12th months. Continuing pain, motor deficits and decreased functional capacity after lumbar disc surgery may also cause loss of work force. In a study on the subject, it was determined that 80% of the patients re-reported due to pain or retired early after a 2-month routine health report after lumbar disc surgery. Controlling pain is important in terms of relaxation of the individual, increasing the quality of life, reducing complications and shortening the length of hospital stay. Pharmacological and non-pharmacological methods are used in the control of pain. One of the non-pharmacological methods is "relaxation". Passive relaxation, biofeedback, autogenic relaxation, basic breathing exercises, and progressive relaxation exercises (PRE) are among the relaxation techniques that require the active participation of the individual. Relaxation therapy has recently become an integral part of the care of individuals with chronic diseases due to its benefits such as reducing anxiety and stress, distracting attention from pain, relieving muscle tension and contractions, facilitating sleep, reducing fatigue and sensitivity to pain. With relaxation therapy, individuals can notice the tensions in their bodies, control their muscles, and learn to relax and relax tense parts of the body. One of the simplest and easiest to learn relaxation techniques is progressive relaxation exercises. These exercises are a series of procedures involving deep breathing and stretching and relaxation cycles in 50 different muscle groups to increase awareness of muscle tension in the body and learn to release these muscles. The technique promotes the systematic relaxation of the main muscle groups of the body for the purpose of physical and mental relaxation, reduction of response to stress, reduction of skeletal muscle contractions and the sensation of pain. In the literature, there are many studies related to progressive relaxation exercises and pain in different patient groups. In studies on musculoskeletal pain, it has been shown that progressive relaxation exercises significantly reduce the pain of patients with chronic neck pain (Lauche et al. 2013), and have a significant effect on pain, stress and disability levels in patients with chronic low back pain. In a systematic review study, it is stated that PRE is effective in reducing chronic low back pain and improving functional status. No study has been found examining the effect of PRE on postoperative pain and disability in patients undergoing lumbar surgery.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Özlem İbrahimoğlu, PhD
  • Phone Number: +905436195971
  • Email: oogutlu@gmail.com

Study Locations

  • Turkey
    • Üsküdar
      • Istanbul, Üsküdar, Turkey
        • Recruiting
        • Sultan 2. Abdulhamid Han Training and Research Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having undergone spinal surgery (such as Discectomy, Laminectomy, Spinal fusion, Foraminatomy),
  • 18 years of age or older
  • Agreeing to apply progressive relaxation exercises and willing and willing to participate in the study,
  • Having no medically diagnosed health problems (neurological, psychiatric, orthopedic) that will prevent learning and practicing progressive muscle relaxation exercises,
  • Patients who do not know and practice progressive relaxation exercises before will be included in the study.

Exclusion Criteria:

  • Patients who will undergo emergency surgery,
  • Do not want to apply progressive relaxation exercises,
  • Do not apply them as desired during the working process,
  • Those have health problems (neurological, psychiatric, orthopedic) that may affect their ability to do the exercises

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercises Group
Patients will be taught Progressive Muscle Relaxation Exercises before the surgery and will be applied twice a week for 2 months after the surgery.
Other: Progressive Muscle Relaxation Exercises
It is among the relaxation techniques that require the active participation of the individual.
No Intervention: Control Group
Patients in the control group will receive standard care that includes all medical and non-medical treatments in the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progressive Muscle Relaxation Exercises
Time Frame: 12 months
Visual Analogue Scale scores will decrease after progressive muscle relaxation exercises. The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad.
12 months
Progressive Muscle Relaxation Exercises
Time Frame: 12 months
Roland-Morris Disability Questionnaire will decrease after progressive muscle relaxation exercises.There will be a total score between 0-24. A high score indicates severe disability.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medeniyet University

Collaborators

Saglik Bilimleri Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

February 22, 2022

First Posted (Actual)

February 23, 2022

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulMU10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will be shared with other researchers by holding a meeting after the data collection is completed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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