Relaxation Exercises for Low Back Pain and Insomnia in the Third Trimester of Pregnancy

NCT05475327 | Completed

• 1 other identifier: REC/RCR & AHS/22/0512
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The role of progressive muscle exercises has been widely explored. However, limited studies report its effectiveness in pregnant women in their third trimester suffering from pain and insomnia that may or may not be due to that pain. This study aims to determine the effects of relaxation exercises on low back pain and insomnia.

Conditions

Low Back Pain

Keywords

Pregnancy; Respiratory training; Sleep disturbance

Outcome Measures

Primary Outcomes (1)

• Roland-Morris Low Back Pain and Disability Questionnaire

  Changes from baseline the Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The RMQ has been shown to yield reliable measurements, which are valid for inferring the level of disability and to be sensitive to change over time for groups of patients with low back pain. Roland and Morris did not provide descriptions of the varying degrees of disability (eg, 40%-60% is a severe disability). A clinical improvement over time can be graded based on the analysis of serial questionnaire scores. If, for example, at the beginning of treatment, a patient's score was 12 and, after treatment, their score was 2 (10 points of improvement), we would calculate an 83% (10/12 x 100) improvement.

  6th week

Secondary Outcomes (2)

• Numeric Pain Rating Scale (NPRS)

  6th week

• Insomnia Severity Index

  6th week

Study Arms (2)

Conventional Physical Therapy

OTHER

Heat therapy and education regarding back care management.

Other: Conventional Physical Therapy

Relaxation exercises

EXPERIMENTAL

Progressive relaxation exercises along with Deep Breathing exercises.

Other: Relaxation exercises

Interventions

Conventional Physical Therapy OTHER

Heating pad A total of 3 sessions per week were given for 15 to 20 mins

Conventional Physical Therapy

Relaxation exercises OTHER

The experimental group was given Progressive relaxation exercises along with Deep breathing exercises. A total of 3 sessions per week were given for 15 to 20 mins.

Relaxation exercises

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Uncomplicated pregnancies
• Chronic back pain for at least 3 months without radiation to legs

You may not qualify if:

• High-risk pregnancy
• Previous spinal surgery
• Structural spinal deformities like scoliosis or Spondylolisthesis
• Diagnosed depression or anxiety
• Diagnosed Disk herniation
• Rheumatic conditions involving the spine

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Bashir Hospital

Sialkot, Punjab Province, 51040, Pakistan

Location

Related Publications (7)

• 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: 24965313 BACKGROUND

• Sadeghi B, Sirati-Nir M, Hajimini Z, Ebadi A, Ali-Asgari M. Comparing the Effects of Progressive Muscle Relaxation and Physical Activity on Pregnant Women's General Health. Iran J Nurs Midwifery Res. 2018 Jul-Aug;23(4):298-304. doi: 10.4103/ijnmr.IJNMR_54_17.

  PMID: 30034491 BACKGROUND

• Ozkan SA, Rathfisch G. The effect of relaxation exercises on sleep quality in pregnant women in the third trimester: A randomized controlled trial. Complement Ther Clin Pract. 2018 Aug;32:79-84. doi: 10.1016/j.ctcp.2018.05.008. Epub 2018 May 26.

  PMID: 30057064 BACKGROUND

• Koukoulithras I Sr, Stamouli A, Kolokotsios S, Plexousakis M Sr, Mavrogiannopoulou C. The Effectiveness of Non-Pharmaceutical Interventions Upon Pregnancy-Related Low Back Pain: A Systematic Review and Meta-Analysis. Cureus. 2021 Jan 30;13(1):e13011. doi: 10.7759/cureus.13011.

  PMID: 33728108 BACKGROUND

• Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.

  PMID: 15928561 BACKGROUND

• Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

  PMID: 11438246 BACKGROUND

• Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24. doi: 10.1097/00007632-200012150-00006. No abstract available.

  PMID: 11124727 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Parasomnias

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Afifa Safdar, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: July 26, 2022
• Study Start: December 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)