NCT05253326

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

2.8 years

First QC Date

February 8, 2022

Last Update Submit

November 16, 2024

Conditions

Keywords

Lumbar SurgeryProgressive muscle relaxationPain

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Exercises Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

It is among the relaxation techniques that require the active participation of the individual.

Exercises Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having undergone spinal surgery (such as Discectomy, Laminectomy, Spinal fusion, Foraminatomy),
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan 2. Abdülhamid Han Training and Research Hospital

Istanbul, Üsküdar, Turkey (Türkiye)

RECRUITING

Related 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.

    PMID: 24965313BACKGROUND
  • 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.

    PMID: 25685400BACKGROUND
  • 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.

    PMID: 27120496BACKGROUND
  • 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.

    PMID: 20728065BACKGROUND
  • 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.

    PMID: 26850172BACKGROUND
  • 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.

    PMID: 16426878BACKGROUND
  • 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.

    PMID: 11740366BACKGROUND
  • 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.

    PMID: 23762355BACKGROUND
  • 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.

    PMID: 27740397BACKGROUND
  • 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.

    PMID: 27022672BACKGROUND
  • 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.

    PMID: 19319578BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Özlem İbrahimoğlu, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 23, 2022

Study Start

May 1, 2022

Primary Completion

February 1, 2025

Study Completion

May 1, 2025

Last Updated

November 19, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

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

Locations