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

Primary Purpose

Spinal Stenosis Lumbar

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Progressive Muscle Relaxation Exercises
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Stenosis Lumbar focused on measuring Lumbar Surgery, Progressive muscle relaxation, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sultan 2. Abdülhamid Han Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercises Group

Control Group

Arm Description

Patients will be taught Progressive Muscle Relaxation Exercises before the surgery and will be applied twice a week for 2 months after the surgery.

Patients in the control group will receive standard care that includes all medical and non-medical treatments in the hospital.

Outcomes

Primary Outcome Measures

Progressive Muscle Relaxation Exercises
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.
Progressive Muscle Relaxation Exercises
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.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2022
Last Updated
September 27, 2023
Sponsor
Istanbul Medeniyet University
Collaborators
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05253326
Brief Title
The Effect of Progressive Muscle Relaxation Exercises on Pain and Disability After Spinal Surgery
Official Title
The Effect of Progressive Muscle Relaxation Exercises on Pain and Disability After Spinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University
Collaborators
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis Lumbar
Keywords
Lumbar Surgery, Progressive muscle relaxation, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercises Group
Arm Type
Experimental
Arm Description
Patients will be taught Progressive Muscle Relaxation Exercises before the surgery and will be applied twice a week for 2 months after the surgery.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients in the control group will receive standard care that includes all medical and non-medical treatments in the hospital.
Intervention Type
Other
Intervention Name(s)
Progressive Muscle Relaxation Exercises
Intervention Description
It is among the relaxation techniques that require the active participation of the individual.
Primary Outcome Measure Information:
Title
Progressive Muscle Relaxation Exercises
Description
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.
Time Frame
12 months
Title
Progressive Muscle Relaxation Exercises
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eda Polat, MSc
Phone
+905415660731
Email
edda_akyol@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Özlem İbrahimoğlu, PhD
Phone
+905436195971
Email
oogutlu@gmail.com
Facility Information:
Facility Name
Sultan 2. Abdülhamid Han Training and Research Hospital
City
Istanbul
State/Province
Üsküdar
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eda Polat, MSc
Phone
+905415660731
Email
edda_akyol@hotmail.com
First Name & Middle Initial & Last Name & Degree
Özlem İbrahimoğlu, PhD
Phone
+905436195971
Email
oogutlu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will be shared with other researchers by holding a meeting after the data collection is completed.
Citations:
PubMed Identifier
24965313
Citation
Akmese ZB, Oran NT. Effects of Progressive Muscle Relaxation Exercises Accompanied by Music on Low Back Pain and Quality of Life During Pregnancy. J Midwifery Womens Health. 2014 Sep-Oct;59(5):503-9. doi: 10.1111/jmwh.12176. Epub 2014 Jun 25.
Results Reference
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PubMed Identifier
25685400
Citation
Atya AM. The validity of spinal mobility for prediction of functional disability in male patients with low back pain. J Adv Res. 2013 Jan;4(1):43-9. doi: 10.1016/j.jare.2012.01.002. Epub 2012 Feb 16.
Results Reference
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PubMed Identifier
27120496
Citation
Casser HR, Seddigh S, Rauschmann M. Acute Lumbar Back Pain. Dtsch Arztebl Int. 2016 Apr 1;113(13):223-34. doi: 10.3238/arztebl.2016.0223.
Results Reference
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PubMed Identifier
20728065
Citation
Chen YL, Francis AJ. Relaxation and imagery for chronic, nonmalignant pain: effects on pain symptoms, quality of life, and mental health. Pain Manag Nurs. 2010 Sep;11(3):159-68. doi: 10.1016/j.pmn.2009.05.005. Epub 2009 Sep 8.
Results Reference
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PubMed Identifier
26850172
Citation
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Results Reference
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PubMed Identifier
16426878
Citation
Hasenbring MI, Plaas H, Fischbein B, Willburger R. The relationship between activity and pain in patients 6 months after lumbar disc surgery: do pain-related coping modes act as moderator variables? Eur J Pain. 2006 Nov;10(8):701-9. doi: 10.1016/j.ejpain.2005.11.004. Epub 2006 Jan 19.
Results Reference
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PubMed Identifier
11740366
Citation
Kucukdeveci AA, Tennant A, Elhan AH, Niyazoglu H. Validation of the Turkish version of the Roland-Morris Disability Questionnaire for use in low back pain. Spine (Phila Pa 1976). 2001 Dec 15;26(24):2738-43. doi: 10.1097/00007632-200112150-00024.
Results Reference
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PubMed Identifier
23762355
Citation
Lauche R, Materdey S, Cramer H, Haller H, Stange R, Dobos G, Rampp T. Effectiveness of home-based cupping massage compared to progressive muscle relaxation in patients with chronic neck pain--a randomized controlled trial. PLoS One. 2013 Jun 7;8(6):e65378. doi: 10.1371/journal.pone.0065378. Print 2013.
Results Reference
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PubMed Identifier
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Citation
Lee CS, Kang KC, Chung SS, Park WH, Shin WJ, Seo YG. How does back muscle strength change after posterior lumbar interbody fusion? J Neurosurg Spine. 2017 Feb;26(2):163-170. doi: 10.3171/2016.7.SPINE151132. Epub 2016 Oct 14.
Results Reference
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Citation
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Citation
Mannion AF, Porchet F, Kleinstuck FS, Lattig F, Jeszenszky D, Bartanusz V, Dvorak J, Grob D. The quality of spine surgery from the patient's perspective. Part 1: the Core Outcome Measures Index in clinical practice. Eur Spine J. 2009 Aug;18 Suppl 3(Suppl 3):367-73. doi: 10.1007/s00586-009-0942-8. Epub 2009 Mar 25.
Results Reference
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The Effect of Progressive Muscle Relaxation Exercises on Pain and Disability After Spinal Surgery

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