Low Back PainNCT05475327
Relaxation Exercises for Low Back Pain and Insomnia in the Third Trimester of Pregnancy
A study testing Conventional Physical Therapy and Relaxation exercises in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Conventional Physical Therapy and Relaxation exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2021to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Uncomplicated pregnancies
- Chronic back pain for at least 3 months without radiation to legs
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Progressive Relaxation Exercises on Low Back Pain and Insomnia in the Third Trimester of Pregnancy
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Conventional Physical Therapy, Relaxation exercises
- Keywords
- Pregnancy, Respiratory training, Sleep disturbance
- Medical subject headings
- Low Back Pain, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physical TherapyOther
Heating pad
A total of 3 sessions per week were given for 15 to 20 mins
Relaxation exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physical Therapy | Other | Heat therapy and education regarding back care management. Receives: Other: Conventional Physical Therapy |
| Relaxation exercises | Experimental | Progressive relaxation exercises along with Deep Breathing exercises. Receives: Other: Relaxation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6th week
Secondary outcomes (2)
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")
Measured: 6th week
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)
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Dec 2021
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Afifa Safdar, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475327
- Sponsor's protocol ID
- REC/RCR & AHS/22/0512
- Status last verified
- Sep 2023
- First submitted
- 24 Jul 2022
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24965313Sadeghi 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.
PubMed 30034491Ozkan 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.
PubMed 30057064Koukoulithras 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.
PubMed 33728108Childs 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.
PubMed 15928561Bastien 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.
PubMed 11438246Roland 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.
PubMed 11124727
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Relaxation Exercises on Low Back Pain and Insomnia in the Third Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT05475327
- Acronym / sponsor ID
- REC/RCR & AHS/22/0512
- Conditions
- Low Back Pain
- Keywords
- Pregnancy, Respiratory training, Sleep disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Physical Therapy | Other | Other: Conventional Physical TherapyHeat therapy and education regarding back care management. |
| Relaxation exercises | Experimental | Other: Relaxation exercisesProgressive relaxation exercises along with Deep Breathing exercises. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Uncomplicated pregnancies
- Chronic back pain for at least 3 months without radiation to legs
Key exclusion criteria (6 listed)
- High-risk pregnancy
- Previous spinal surgery
- Structural spinal deformities like scoliosis or Spondylolisthesis
- Diagnosed depression or anxiety
- Diagnosed Disk herniation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Physical TherapyHeating pad A total of 3 sessions per week were given for 15 to 20 mins | Other | Conventional Physical Therapy |
| Relaxation exercisesThe 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. | Other | Relaxation exercises |
Primary outcome
Roland-Morris Low Back Pain and Disability Questionnaire
Time frame: 6th week
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.
2 secondary outcomes
Numeric Pain Rating Scale (NPRS)
Time frame: 6th week
Insomnia Severity Index
Time frame: 6th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Background: PubMed 24965313Akmese 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.
- Background: PubMed 30034491Sadeghi 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.
- Background: PubMed 30057064Ozkan 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.
- Background: PubMed 33728108Koukoulithras 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.
- Background: PubMed 15928561Childs 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.
- Background: PubMed 11438246Bastien 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.
- Background: PubMed 11124727Roland 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Afifa Safdar, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physical Therapy and Relaxation exercises in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland-Morris Low Back Pain and Disability Questionnaire (time frame: 6th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05475327, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.