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

Spinal Stenosis Lumbar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05253326
• Other study ID #: IstanbulMU10
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: November 2023
• Source: Istanbul Medeniyet University
• Contact: Eda Polat, MSc
• Phone: +905415660731
• Email: edda_akyol[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Stenosis
• Spinal Stenosis Lumbar

Intervention

Other:
• Progressive Muscle Relaxation Exercises
It is among the relaxation techniques that require the active participation of the individual.

Locations

Country	Name	City	State
Turkey	Sultan 2. Abdülhamid Han Training and Research Hospital	Istanbul	Üsküdar

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul Medeniyet University	Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View Citation

Fekete TF, Haschtmann D, Kleinstuck FS, Porchet F, Jeszenszky D, Mannion AF. What level of pain are patients happy to live with after surgery for lumbar degenerative disorders? Spine J. 2016 Apr;16(4 Suppl):S12-8. doi: 10.1016/j.spinee.2016.01.180. Epub 2016 Feb 2. — View 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. — View 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. — View 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. — View 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. — View Citation

Mancuso CA, Reid MC, Duculan R, Girardi FP. Improvement in Pain After Lumbar Spine Surgery: The Role of Preoperative Expectations of Pain Relief. Clin J Pain. 2017 Feb;33(2):93-98. doi: 10.1097/AJP.0000000000000383. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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.	12 months