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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional Physical Therapy
Relaxation exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Pregnancy, Respiratory training, Sleep disturbance

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Bashir Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Conventional Physical Therapy

Relaxation exercises

Arm Description

Heat therapy and education regarding back care management.

Progressive relaxation exercises along with Deep Breathing exercises.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Numeric Pain Rating Scale (NPRS)
Changes from baseline the Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Insomnia Severity Index
Changes from baseline the Insomnia Severity Index has seven questions. The seven answers are added up to get a total score. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)

Full Information

First Posted
July 24, 2022
Last Updated
September 15, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05475327
Brief Title
Relaxation Exercises for Low Back Pain and Insomnia in the Third Trimester of Pregnancy
Official Title
Effects of Progressive Relaxation Exercises on Low Back Pain and Insomnia in the Third Trimester of Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

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
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.
Detailed Description
In 2021 the research says that most women experience pubic pain, hip pain, knee pain, leg cramps, carpal tunnel syndrome, De Quervain's tenosynovitis, or at least one of these symptoms during pregnancy and approximately one-quarter of them have a temporary disability. Symptoms of LBP could start from early in pregnancy until giving birth, but usually, the pain becomes more severe during the third semester of pregnancy and is described as a dull pain. In most cases of LBP, the pain does not radiate to other parts of the body. The exercise was found to be a very common practice used to decrease LBP and the majority of the relative studies were categorized as of high methodological quality. The exercise components of the interventions included strength and stretching, endurance training, pelvic tilt exercises, stretching and mild isometric abdominal contractions, progressive muscle relaxation exercises accompanied by music as well as aerobic and stretching exercises. Another research in 2021 describe that one of the most common complaints during pregnancy is sleep disorders, such as insomnia, frequently waking up at night, high drowsiness during the day, mood swings, and unusual feelings during sleep results of the present study showed that counseling with a spiritual approach was effective in improving the sleep quality in pregnant women. In the intervention group, the mean score of sleep quality decreased in the second and third trimesters compared to the control group. In the present study, spiritual content counseling had a significant effect on all areas of sleep quality, except for habitual sleep efficiency. In 2018 one of research says that physiological and psychological changes in the third trimester of pregnancy make falling asleep at night more difficult for pregnant women. Studies also show that relaxation exercises reduce psychological tension, stress, and pain. The pregnant women in the relaxation exercises group of the present study reported falling asleep more comfortably as a result of the decrease in muscle tension, stress, and pain perception. The four-week relaxation exercises improved subjective sleep latency, duration, habitual sleep efficiency, sleep disturbances, daytime dysfunction, and sleep quality of the pregnant women in the third trimester. Another research in 2018 on the effects of breathing exercises on insomnia. This study finding revealed that, pre-intervention more than half of the pregnant women experienced severe insomnia this may be attributed to the inflammation process of pregnancy and the effect of pregnancy physiological and psychological changes and discomforts on the sleep cycle. The present study revealed that the total score of insomnia decreased for the majority of pregnant women after practicing walking with deep breathing exercises. This can be attributed to the positive effect of exercises i.e walking or breathing exercises on the overall health either physical or psychological by improving physical fitness, increasing the blood supply and the circulation to the brain to enhance the sleep cycle, and improving the quality of sleep and decrease the insomnia symptoms. It has a positive effect on the severity of insomnia during the third trimester of pregnancy, tension, and fatigue relief. Another research in 2014 says that relaxation therapy and progressive muscle relaxation (PMR) are forms of complementary and alternative medicine often used in pregnancy. There are several reasons why this therapy might produce the observed benefit. PMR-induced reduction in anxiety and decreased perception of pain may eventually improve QOL status in pregnant women. In one study, PMR intervention was compared with massage in pregnant women with leg and back pain. In that study, leg pain decreased significantly after the first and last treatments in both the PMR and massage groups, but back pain decreased only in the massage group. Pain decreased over time during the study in the intervention group, whereas the pain scores (and perceived pain) in the control group increased gradually. LBP is one of the most common symptoms in pregnancy. We conclude that PMR training can reduce LBP and improve QOL in pregnant women. Most of the research was conducted on low back pain with pelvic girdle pain, the effect of relaxation exercises with music on low back pain, the effect of relaxation exercises on insomnia, and quality of life. The objective of this research is to determine the effect of progressive relaxation exercises on low back pain and insomnia in the third trimester of pregnancy and show the combined effect of relaxation. Reviewing the previous literature on the effects of exercises on low back pain and insomnia provides sufficient data but there is not enough data on the effects of a combination of both exercise on insomnia and low back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Pregnancy, Respiratory training, Sleep disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Physical Therapy
Arm Type
Other
Arm Description
Heat therapy and education regarding back care management.
Arm Title
Relaxation exercises
Arm Type
Experimental
Arm Description
Progressive relaxation exercises along with Deep Breathing exercises.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
Heating pad A total of 3 sessions per week were given for 15 to 20 mins
Intervention Type
Other
Intervention Name(s)
Relaxation exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Roland-Morris Low Back Pain and Disability Questionnaire
Description
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.
Time Frame
6th week
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
Changes from baseline the Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time Frame
6th week
Title
Insomnia Severity Index
Description
Changes from baseline the Insomnia Severity Index has seven questions. The seven answers are added up to get a total score. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Time Frame
6th week

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Uncomplicated pregnancies Chronic back pain for at least 3 months without radiation to legs Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afifa Safdar, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bashir Hospital
City
Sialkot
State/Province
Punjab
ZIP/Postal Code
51040
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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
background
PubMed Identifier
30034491
Citation
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.
Results Reference
background
PubMed Identifier
30057064
Citation
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.
Results Reference
background
PubMed Identifier
33728108
Citation
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.
Results Reference
background
PubMed Identifier
15928561
Citation
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.
Results Reference
background
PubMed Identifier
11438246
Citation
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.
Results Reference
background
PubMed Identifier
11124727
Citation
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. Erratum In: Spine 2001 Apr 1;26(7):847.
Results Reference
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Relaxation Exercises for Low Back Pain and Insomnia in the Third Trimester of Pregnancy

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