Low Back PainSTMNCT03433404
Soft Tissue Mobilization for Lumbopelvic Pain in the Third Trimester of Pregnancy
A study testing Soft Tissue Mobilization and Soft Tissue Massage in people with Low Back Pain and Pregnancy, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
Back pain is one of the most common complaints in pregnancy. It is caused by the growing pregnant abdomen which then strains the lower back and pelvis. Often Obstetricians recommend rest, Tylenol, pelvic support belts, or exercise. Typically, these do not provide the patient much relief. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Pregnancy
- What is being tested?
- Soft Tissue Mobilization and Soft Tissue Massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 14 Dec 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects 18-45 years old
- singleton gestation in the third trimester (28 weeks and on)
- pregnancy-related lumbopelvic pain
- capable of following basic instructions.
Who cannot join
- Subjects with a history of lumbopelvic pain that required healthcare management within a year prior to pregnancy
- acute infectious or inflammatory process
- diagnosed mental health disorder
- substance abuse
- documented diagnosis of fibromyalgia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
About this study
Back pain is one of the most common complaints in pregnancy. It is caused by the growing pregnant abdomen which then strains the lower back and pelvis. Often Obstetricians recommend rest, Tylenol, pelvic support belts, or exercise. Typically, these do not provide the patient much relief. A physical therapy treatment known as soft tissue mobilization (tSTM) has been shown to be helpful in treating various types of pain. This study will explore whether tSTM can improve back pain in pregnancy.
Read the detailed description
Context: Lumbopelvic pain is one of the most common complaints in pregnancy, as increasing hormone levels cause joint laxity and the gravid uterus weakens abdominal muscles and increases lumbar muscle strain. Obstetricians often recommend rest, exercise, heating pad application, acetaminophen, or pelvic support belts. Patients often complain of minimal relief from these recommendations. Many experience recurrent lumbopelvic pain in a subsequent pregnancy. Additionally, lumbopelvic pain can contribute to disability and sick leave during the pregnancy. This is the first study to investigate whether soft tissue mobilization improves lumbopelvic pain in the third trimester.
Objective: To investigate whether a physical therapy intervention known as transverse friction massage or soft tissue mobilization improves third trimester pregnancy related lumbopelvic pain.
Design: Randomized pre-test and post-test comparison group design. Setting: Texas Tech University Health Sciences Center, Center for Rehabilitation Research, Lubbock, TX, USA.
Participants: 48 subjects between the 18-45 years of age with a singleton gestation in the third trimester with pregnancy related lumbopelvic pain.
Methods: Subjects consented for the study will be diagnosed by the Obstetrician with PRLPP by clinical tests, including the posterior pelvic pain provocation test, active straight leg raise test, and the long dorsal sacroiliac ligament test. Subjects will be randomized to one of three groups: no manual treatment (noManRx), superficial massage (sMass), and soft tissue mobilization (tSTM). All groups will receive standard care, which includes acetaminophen, heating pad application, and/or rest. Subjective questionnaires including the numeric pain rating scale (NPRS), the Oswestry Disability Index (ODI), and the Global Rating of Change (GROC) will be administered for baseline prior to allocated intervention. The Pressure Pain Threshold (PPT) will be measured via algometry. Those receiving sMass and tSTM will receive prescribed standard care as well as sMass or tSTM every 1-2 weeks by an investigator as well as daily sMass or tSTM at home.
Main outcome measures: (1) Pain using NPRS, (2) disability using ODI, (3) overall change in pain pre- and post-treatment using GROC, (4) pressure pain threshold via algometry.
Expected results: It is anticipated that this soft tissue mobilization technique known as transverse friction massage will decrease lumbopelvic pain in the third trimester of pregnancy.
- Conditions
- Low Back Pain, Pregnancy
- Being tested
- Soft Tissue Mobilization, Soft Tissue Massage
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft Tissue MobilizationProcedure or surgery
The technique has been described previously in other descriptions. However, the main goal of this treatment is to address the LDSIL in the manner described previously in order to mobilize the soft tissue in the area.
Soft Tissue MassageProcedure or surgery
For sMass, the subject will be positioned on her side opposite to the most painful side of the lumbosacral spine with the hips flexed to 45 degrees and knees flexed to 90 degrees (with a pillow positioned between them). The investigator will perform superficial (light stroke) massage to the painful side of the lumbosacral region for 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| Soft Tissue Mobilization | Experimental | The arm will utilize a Physical Therapy technique call soft tissue mobilization. Receives: Procedure: Soft Tissue Mobilization |
| Soft Tissue Massage | Active comparator | This arm will utilize standard soft tissue massage applied to the low back in pregnant patients complaining of third trimester low back pain. Receives: Procedure: Soft Tissue Massage |
| No manual treatment | No intervention | Group will still receive acetaminophen, heating pad application, and/or rest which is standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain using NPRS (Numerical Pain Rating Scale)
The NPRS is a scale from 0 to 10 that is commonly used to measure intensity of pain, with 0 representing no pain and 10 representing extreme pain. It is easy to understand and complete that is also valid and reliable. Due to the nature of fluctuating intensity of pain, subjects will use a NPRS to log their current pain, least pain, and most pain each day at home and at the obstetric clinic before the respective treatment. The daily pain score will be averaged, then averaged across each week. The NPRS scores will be also be used to evaluate the change between the overall pain level at the beginning and end of subject's participation. The aim throughout the study is to see a reduction in the overall numerical pain scale rating. For example, if a patient comes in with a pain scale rating of 10, the hope is that after a series of treatments, the pain scale will go down to indicate an improvement in overall pain.
Measured: through study completion, an average of 1 year
disability using ODI (Oswestry Disability Index)
Back pain and its effect on disability can be evaluated using the ODI. It is a brief 10 question survey on the effect of back pain on daily activities, such as personal care, walking, lifting, sitting, standing, sex life, social life, traveling. Each answer in each section is scored 0 to 5, 0 if the first box is checked (0 if it causes no disability) and 5 (maximal disability) if the last box is checked. The final score is expressed as a percentage out of a total score of 50. It is usually used for lumbar back pain, but has been shown to be specifically valid for sacroiliac joint pain. The ODI questionnaire will be filled out by subjects at the initial session and at the end of the final treatment session.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Dec 2019
- Primary completion1 Dec 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433404
- Sponsor's protocol ID
- L17-191
- Acronym
- STM
- Status last verified
- Jul 2023
- First submitted
- 29 Jan 2018
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Mobilization for Lumbopelvic Pain in the Third Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT03433404
- Acronym / sponsor ID
- STM / L17-191
- Conditions
- Low Back Pain, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 14 Feb 2018 (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.
Back pain is one of the most common complaints in pregnancy. It is caused by the growing pregnant abdomen which then strains the lower back and pelvis. Often Obstetricians recommend rest, Tylenol, pelvic support belts, or exercise. Typically, these do not provide the patient much relief. A physical therapy treatment known as soft tissue mobilization (tSTM) has been shown to be helpful in treating various types of pain. This study will explore whether tSTM can improve back pain in pregnancy.
Detailed description
Context: Lumbopelvic pain is one of the most common complaints in pregnancy, as increasing hormone levels cause joint laxity and the gravid uterus weakens abdominal muscles and increases lumbar muscle strain. Obstetricians often recommend rest, exercise, heating pad application, acetaminophen, or pelvic support belts. Patients often complain of minimal relief from these recommendations. Many experience recurrent lumbopelvic pain in a subsequent pregnancy. Additionally, lumbopelvic pain can contribute to disability and sick leave during the pregnancy. This is the first study to investigate whether soft tissue mobilization improves lumbopelvic pain in the third trimester.
Objective: To investigate whether a physical therapy intervention known as transverse friction massage or soft tissue mobilization improves third trimester pregnancy related lumbopelvic pain.
Design: Randomized pre-test and post-test comparison group design. Setting: Texas Tech University Health Sciences Center, Center for Rehabilitation Research, Lubbock, TX, USA.
Participants: 48 subjects between the 18-45 years of age with a singleton gestation in the third trimester with pregnancy related lumbopelvic pain.
Methods: Subjects consented for the study will be diagnosed by the Obstetrician with PRLPP by clinical tests, including the posterior pelvic pain provocation test, active straight leg raise test, and the long dorsal sacroiliac ligament test. Subjects will be randomized to one of three groups: no manual treatment (noManRx), superficial massage (sMass), and soft tissue mobilization (tSTM). All groups will receive standard care, which includes acetaminophen, heating pad application, and/or rest. Subjective questionnaires including the numeric pain rating scale (NPRS), the Oswestry Disability Index (ODI), and the Global Rating of Change (GROC) will be administered for baseline prior to allocated intervention. The Pressure Pain Threshold (PPT) will be measured via algometry. Those receiving sMass and tSTM will receive prescribed standard care as well as sMass or tSTM every 1-2 weeks by an investigator as well as daily sMass or tSTM at home.
Main outcome measures: (1) Pain using NPRS, (2) disability using ODI, (3) overall change in pain pre- and post-treatment using GROC, (4) pressure pain threshold via algometry.
Expected results: It is anticipated that this soft tissue mobilization technique known as transverse friction massage will decrease lumbopelvic pain in the third trimester of pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Soft Tissue Mobilization | Experimental | Procedure: Soft Tissue MobilizationThe arm will utilize a Physical Therapy technique call soft tissue mobilization. |
| Soft Tissue Massage | Active comparator | Procedure: Soft Tissue MassageThis arm will utilize standard soft tissue massage applied to the low back in pregnant patients complaining of third trimester low back pain. |
| No manual treatment | No intervention | –Group will still receive acetaminophen, heating pad application, and/or rest which is standard of care. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects 18-45 years old
- singleton gestation in the third trimester (28 weeks and on)
- pregnancy-related lumbopelvic pain
- capable of following basic instructions.
Key exclusion criteria (5 listed)
- Subjects with a history of lumbopelvic pain that required healthcare management within a year prior to pregnancy
- acute infectious or inflammatory process
- diagnosed mental health disorder
- substance abuse
- documented diagnosis of fibromyalgia.
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 |
|---|---|---|
| Soft Tissue MobilizationThe technique has been described previously in other descriptions. However, the main goal of this treatment is to address the LDSIL in the manner described previously in order to mobilize the soft tissue in the area. | Procedure or surgery | Soft Tissue Mobilization |
| Soft Tissue MassageFor sMass, the subject will be positioned on her side opposite to the most painful side of the lumbosacral spine with the hips flexed to 45 degrees and knees flexed to 90 degrees (with a pillow positioned between them). The investigator will perform superficial (light stroke) massage to the painful side of the lumbosacral region for 5 minutes | Procedure or surgery | Soft Tissue Massage |
Primary outcome
Pain using NPRS (Numerical Pain Rating Scale)
Time frame: through study completion, an average of 1 year
The NPRS is a scale from 0 to 10 that is commonly used to measure intensity of pain, with 0 representing no pain and 10 representing extreme pain. It is easy to understand and complete that is also valid and reliable. Due to the nature of fluctuating intensity of pain, subjects will use a NPRS to log their current pain, least pain, and most pain each day at home and at the obstetric clinic before the respective treatment. The daily pain score will be averaged, then averaged across each week. The NPRS scores will be also be used to evaluate the change between the overall pain level at the beginning and end of subject's participation. The aim throughout the study is to see a reduction in the overall numerical pain scale rating. For example, if a patient comes in with a pain scale rating of 10, the hope is that after a series of treatments, the pain scale will go down to indicate an improvement in overall pain.
disability using ODI (Oswestry Disability Index)
Time frame: through study completion, an average of 1 year
Back pain and its effect on disability can be evaluated using the ODI. It is a brief 10 question survey on the effect of back pain on daily activities, such as personal care, walking, lifting, sitting, standing, sex life, social life, traveling. Each answer in each section is scored 0 to 5, 0 if the first box is checked (0 if it causes no disability) and 5 (maximal disability) if the last box is checked. The final score is expressed as a percentage out of a total score of 50. It is usually used for lumbar back pain, but has been shown to be specifically valid for sacroiliac joint pain. The ODI questionnaire will be filled out by subjects at the initial session and at the end of the final treatment session.
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 6 Jul 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft Tissue Mobilization and Soft Tissue Massage in people with Low Back Pain and Pregnancy, run by Texas Tech University Health Sciences Center at 1 site in United States.
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 4 inclusion and 5 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 6 Jul 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 United States. 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?
Pain using NPRS (Numerical Pain Rating Scale) (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2023.