Back PainNCT03787979
Relative Stiffness of Lumbar Spine and Hamstrings Muscle Stretching
A study testing Lumbopelvic stiffening technique and Lumbopelvic relaxing technique in people with Back Pain and Instability Lumbar Spine, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to investigate the effect of lumbopelvic stabilization on hamstrings muscle stretching in individuals with history of low back pain suspected to have a clinical lumbar instability. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Back Pain, Instability Lumbar Spine, Muscle Tightness
- What is being tested?
- Lumbopelvic stiffening technique and Lumbopelvic relaxing technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteThailand
- Study dates
- 24 Dec 2018to 30 May 2019
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 20 and 40
- A recurrent pattern of LBP at least two episodes that interfered with activities of daily living and/or required treatment
- Presenting aberrant movement pattern during active forward bend test
- Passive straight leg raising test (SLR) greater than 91 degrees
- Having hamstrings muscle tightness of both legs (passive knee extension in supine with 90° hip flexion position greater than 20 degrees)
Who cannot join
- Having a history of abdominal, back surgery and/or fracture.
- Having any red flags, such as infection, tumor, fracture, radicular syndrome, or inflammatory.
- Pregnancy or having menstruation.
- Having spinal deformities, such as scoliosis.
- Having neurological, musculoskeletal or cardiopulmonary diseases.
- Previously receiving physical therapy intervention involving in motor control training.
Show all 10Show fewer
- Taking muscle relaxant medication.
- Having hip joint stiffness or pain
- Having positive Trendelenburg's sign.
- Currently having routine vigorous exercise.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Physical Therapy, Mahidol University
Salaya, Changwat Nakhon Pathom, 73170
About this study
Official title: Effect of Increased Relative Stiffness of Lumbar Spine on Hamstrings Muscle Stretching in Individuals With History of Low Back Pain Suspected to Have a Clinical Lumbar Instability
The purpose of this study is to investigate the effect of lumbopelvic stabilization on hamstrings muscle stretching in individuals with history of low back pain suspected to have a clinical lumbar instability.
Read the detailed description
The participants between the age of 20 and 40 years with history of low back pain will be recruited from Mahidol University using a poster posted at Faculty of Physical Therapy. All participants will be explained the purposes, advantages, disadvantages and procedures of the study by the researcher. The participant will be asked to sign an informed consent if the participants are willing to participate in this study.
After obtaining the written informed consent, the researcher, who works in musculoskeletal system including low back pain for 7 years and has received 3 training sessions on clinical observation of aberrant movement, will perform 2 clinical tests including clinical observation of aberrant movement patterns and passive straight leg raising test to identify clinical lumbar instability, and measure hamstrings muscle length using clinical motion analysis system. The researcher will also screen for exclusion criteria using a check list.
For those who are qualified for the study, the participants will be asked to fill out the demographic data and physical activity questionnaire. The researcher will perform additional clinical examination including modified Thomas test, back extensor muscle strength test assessed by a handheld dynamometer, Trendelenburg's test and lumbar stability test. After clinical tests, lumbopelvic, pelvic, and lumbar range of motions during an active forward bend task will be measured by using the clinical motion analysis system. These outcome measures will be assessed for baseline (Pre-1). After baseline data collection, the participants will be divided into 2 groups; lumbopelvic stiffening group (LS) or lumbopelvic relaxing group (LR) by randomly generated code in a concealed envelope.
The participants in LS group will stretch the hamstrings muscle in standing position with lumbopelvic stabilization. Fifteen percent of the body weight will be used to standardize stretching force. This force will be controlled by visual feedback from load cell. During stretching protocol, the participants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. Researcher commands "during adjusting the bed up, please tense the lower back rigid". After that, hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions. To ensure that participant correctly performs lumbopelvic stabilization, the researcher will palpate at ASIS and iliac crest to check pelvic motion during hamstrings muscle stretching. Pelvic motion indicates loss of lumbopelvic stabilization. Participant will be asked to re-perform another repetition. Our protocol is based on a previous study by DePino et al., 2000. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions. The investigators use 30 seconds because a systematic review suggests that 30 seconds is the most effective dose for hamstrings muscle stretching.
For the participants in LR group, the participants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. The researcher commands "During adjusting the bed up, please relax the lower back". The hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions.
After the intervention, the participants will be reassessed for hamstrings muscle length test, lumbar motion, pelvic motion and total lumbopelvic motion (Post-1). Because this study uses a cross-over study design, participants will be asked to maintain the usual physical activity for 2 days as a wash-out period. Then, the participants will be re-assessed for baseline data (Pre-2), and cross-over to another stretching group (LS changes to LR, while LR changes to LS). After completion of intervention, the participants will be re-assessed for post-intervention (Post-2). These to determine the effectiveness of lumbopelvic stabilization during hamstrings stretching in standing.
- Conditions
- Back Pain, Instability Lumbar Spine, Muscle Tightness
- Being tested
- Lumbopelvic stiffening technique, Lumbopelvic relaxing technique
- Keywords
- History of low back pain, Clinical lumbar instability, Stretching exercise
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbopelvic stiffening techniqueOther
Participants will stretch their hamstrings muscle in standing position with lumbopelvic stiffening technique. Fifteen percent of the body weight will be used to standardize stretching force. During stretching protocol, the participants will be instructed to face the hydraulic table with their hips square, maintain trunk straight up and look straight ahead. Researcher commands "during adjusting the bed up, please tense your back rigid". After that, hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions.
Lumbopelvic relaxing techniqueOther
Participants will be instructed to face the hydraulic table with their hips square, maintain trunk straight up and look straight ahead. The researcher commands "During adjusting the bed up, please relax your back". The hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Lumbopelvic stiffening technique | Experimental | Hamstring muscle stretching with lumbopelvic stiffening technique. Receives: Other: Lumbopelvic stiffening technique; Other: Lumbopelvic relaxing technique |
| Lumbopelvic relaxing technique | Active comparator | Hamstrings muscle stretching with lumbopelvic relaxing technique. Receives: Other: Lumbopelvic stiffening technique; Other: Lumbopelvic relaxing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar, pelvic, and lumbopelvic motions at baseline.
Clinical motion analysis system will be used to measure these segmental motions. This system is composed of triple axis accelerometers (MPU6050, China), data acquisition board (Arduino Uno R3, Italy), and a LabVIEW software version 2012 (National Instrument, USA). The system will be used to measure pre- and post-intervention of angle of lumbar, pelvic, and lumbopelvic motions through a custom LabVIEW program at 100 Hz.
Measured: These data will be collected at baseline and immediately after intervention.
Lumbar, pelvic, and lumbopelvic motions after intervention.
Clinical motion analysis system will be used to measure these segmental motions. This system is composed of triple axis accelerometers (MPU6050, China), data acquisition board (Arduino Uno R3, Italy), and a LabVIEW software version 2012 (National Instrument, USA). The system will be used to measure pre- and post-intervention of angle of lumbar, pelvic, and lumbopelvic motions through a custom LabVIEW program at 100 Hz.
Measured: These data will be collected at immediately after intervention.
Hamstrings muscle length at baseline.
Clinical motion analysis system will be used to measure the angle of knee extension that represents hamstrings muscle length at pre- and post-intervention.
Measured: These data will be collected at baseline.
Hamstrings muscle length after intervention.
Clinical motion analysis system will be used to measure the angle of knee extension that represents hamstrings muscle length at pre- and post-intervention.
Measured: These data will be collected at immediately after intervention.
Secondary outcomes (2)
Muscle length based on modified Thomas and Trendelenburg test.
Clinical tests will be performed at the baseline because they could be a potential confounding factor.
Measured: These data will be collected at baseline only.
Abdominal and back muscle strength .
Abdominal and back muscle strengths will be measured by using a hand-held dynamometer. Clinical tests will be performed at the baseline because they could be a potential confounding factor.
Measured: These data will be collected at baseline only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start24 Dec 2018
- Primary completion30 Apr 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Crossover
- Model description
- Participants will be randomly assigned to either stretching exercise with lumbopelvic stiffening technique or lumbopelvic relaxing technique. They will be provided a 2-day wash-out period. Then, participants will cross-over to another technique.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peemongkon Wattananon, Mahidol University
- Investigators
- Peemongkon Wattananon, PhD, Principal investigator, Faculty of Physical Therapy, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787979
- Sponsor's protocol ID
- 2018/200.1010
- Status last verified
- May 2019
- First submitted
- 19 Dec 2018
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD of this study will be shared upon official request.
Publications
Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.
PubMed 16181938Sahrmann S, Azevedo DC, Dillen LV. Diagnosis and treatment of movement system impairment syndromes. Braz J Phys Ther. 2017 Nov-Dec;21(6):391-399. doi: 10.1016/j.bjpt.2017.08.001. Epub 2017 Sep 27.
PubMed 29097026Jandre Reis FJ, Macedo AR. Influence of Hamstring Tightness in Pelvic, Lumbar and Trunk Range of Motion in Low Back Pain and Asymptomatic Volunteers during Forward Bending. Asian Spine J. 2015 Aug;9(4):535-40. doi: 10.4184/asj.2015.9.4.535. Epub 2015 Jul 28.
PubMed 26240711Wattananon P, Prasertkul W, Sakulsriprasert P, Laskin JJ. Effect of increased relative stiffness of the lumbar spine on hamstring muscle stretching in individuals with a history of low back pain suspected to have a clinical lumbar instability: A randomized crossover design. Clin Biomech (Bristol). 2020 May;75:104996. doi: 10.1016/j.clinbiomech.2020.104996. Epub 2020 Apr 20.
PubMed 32339943
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Increased Relative Stiffness of Lumbar Spine on Hamstrings Muscle Stretching in Individuals With History of Low Back Pain Suspected to Have a Clinical Lumbar Instability
- ClinicalTrials.gov ID
- NCT03787979
- Acronym / sponsor ID
- 2018/200.1010
- Conditions
- Back Pain, Instability Lumbar Spine, Muscle Tightness
- Keywords
- History of low back pain, Clinical lumbar instability, Stretching exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 24 Dec 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 27 Dec 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.
The purpose of this study is to investigate the effect of lumbopelvic stabilization on hamstrings muscle stretching in individuals with history of low back pain suspected to have a clinical lumbar instability.
Detailed description
The participants between the age of 20 and 40 years with history of low back pain will be recruited from Mahidol University using a poster posted at Faculty of Physical Therapy. All participants will be explained the purposes, advantages, disadvantages and procedures of the study by the researcher. The participant will be asked to sign an informed consent if the participants are willing to participate in this study.
After obtaining the written informed consent, the researcher, who works in musculoskeletal system including low back pain for 7 years and has received 3 training sessions on clinical observation of aberrant movement, will perform 2 clinical tests including clinical observation of aberrant movement patterns and passive straight leg raising test to identify clinical lumbar instability, and measure hamstrings muscle length using clinical motion analysis system. The researcher will also screen for exclusion criteria using a check list.
For those who are qualified for the study, the participants will be asked to fill out the demographic data and physical activity questionnaire. The researcher will perform additional clinical examination including modified Thomas test, back extensor muscle strength test assessed by a handheld dynamometer, Trendelenburg's test and lumbar stability test. After clinical tests, lumbopelvic, pelvic, and lumbar range of motions during an active forward bend task will be measured by using the clinical motion analysis system. These outcome measures will be assessed for baseline (Pre-1). After baseline data collection, the participants will be divided into 2 groups; lumbopelvic stiffening group (LS) or lumbopelvic relaxing group (LR) by randomly generated code in a concealed envelope.
The participants in LS group will stretch the hamstrings muscle in standing position with lumbopelvic stabilization. Fifteen percent of the body weight will be used to standardize stretching force. This force will be controlled by visual feedback from load cell. During stretching protocol, the participants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. Researcher commands "during adjusting the bed up, please tense the lower back rigid". After that, hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions. To ensure that participant correctly performs lumbopelvic stabilization, the researcher will palpate at ASIS and iliac crest to check pelvic motion during hamstrings muscle stretching. Pelvic motion indicates loss of lumbopelvic stabilization. Participant will be asked to re-perform another repetition. Our protocol is based on a previous study by DePino et al., 2000. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions. The investigators use 30 seconds because a systematic review suggests that 30 seconds is the most effective dose for hamstrings muscle stretching.
For the participants in LR group, the participants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. The researcher commands "During adjusting the bed up, please relax the lower back". The hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions.
After the intervention, the participants will be reassessed for hamstrings muscle length test, lumbar motion, pelvic motion and total lumbopelvic motion (Post-1). Because this study uses a cross-over study design, participants will be asked to maintain the usual physical activity for 2 days as a wash-out period. Then, the participants will be re-assessed for baseline data (Pre-2), and cross-over to another stretching group (LS changes to LR, while LR changes to LS). After completion of intervention, the participants will be re-assessed for post-intervention (Post-2). These to determine the effectiveness of lumbopelvic stabilization during hamstrings stretching in standing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either stretching exercise with lumbopelvic stiffening technique or lumbopelvic relaxing technique. They will be provided a 2-day wash-out period. Then, participants will cross-over to another technique.
| Arm | Type | Receives |
|---|---|---|
| Lumbopelvic stiffening technique | Experimental | Other: Lumbopelvic stiffening technique, Other: Lumbopelvic relaxing techniqueHamstring muscle stretching with lumbopelvic stiffening technique. |
| Lumbopelvic relaxing technique | Active comparator | Other: Lumbopelvic stiffening technique, Other: Lumbopelvic relaxing techniqueHamstrings muscle stretching with lumbopelvic relaxing technique. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between the ages of 20 and 40
- A recurrent pattern of LBP at least two episodes that interfered with activities of daily living and/or required treatment
- Presenting aberrant movement pattern during active forward bend test
- Passive straight leg raising test (SLR) greater than 91 degrees
- Having hamstrings muscle tightness of both legs (passive knee extension in supine with 90° hip flexion position greater than 20 degrees)
Key exclusion criteria (10 listed)
- Having a history of abdominal, back surgery and/or fracture.
- Having any red flags, such as infection, tumor, fracture, radicular syndrome, or inflammatory.
- Pregnancy or having menstruation.
- Having spinal deformities, such as scoliosis.
- Having neurological, musculoskeletal or cardiopulmonary diseases.
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 |
|---|---|---|
| Lumbopelvic stiffening techniqueParticipants will stretch their hamstrings muscle in standing position with lumbopelvic stiffening technique. Fifteen percent of the body weight will be used to standardize stretching force. During stretching protocol, the participants will be instructed to face the hydraulic table with their hips square, maintain trunk straight up and look straight ahead. Researcher commands "during adjusting the bed up, please tense your back rigid". After that, hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions. | Other | Lumbopelvic relaxing technique, Lumbopelvic stiffening technique |
| Lumbopelvic relaxing techniqueParticipants will be instructed to face the hydraulic table with their hips square, maintain trunk straight up and look straight ahead. The researcher commands "During adjusting the bed up, please relax your back". The hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions. | Other | Lumbopelvic relaxing technique, Lumbopelvic stiffening technique |
Primary outcome
Lumbar, pelvic, and lumbopelvic motions at baseline.
Time frame: These data will be collected at baseline and immediately after intervention.
Clinical motion analysis system will be used to measure these segmental motions. This system is composed of triple axis accelerometers (MPU6050, China), data acquisition board (Arduino Uno R3, Italy), and a LabVIEW software version 2012 (National Instrument, USA). The system will be used to measure pre- and post-intervention of angle of lumbar, pelvic, and lumbopelvic motions through a custom LabVIEW program at 100 Hz.
Lumbar, pelvic, and lumbopelvic motions after intervention.
Time frame: These data will be collected at immediately after intervention.
Clinical motion analysis system will be used to measure these segmental motions. This system is composed of triple axis accelerometers (MPU6050, China), data acquisition board (Arduino Uno R3, Italy), and a LabVIEW software version 2012 (National Instrument, USA). The system will be used to measure pre- and post-intervention of angle of lumbar, pelvic, and lumbopelvic motions through a custom LabVIEW program at 100 Hz.
Hamstrings muscle length at baseline.
Time frame: These data will be collected at baseline.
Clinical motion analysis system will be used to measure the angle of knee extension that represents hamstrings muscle length at pre- and post-intervention.
Hamstrings muscle length after intervention.
Time frame: These data will be collected at immediately after intervention.
Clinical motion analysis system will be used to measure the angle of knee extension that represents hamstrings muscle length at pre- and post-intervention.
2 secondary outcomes
Muscle length based on modified Thomas and Trendelenburg test.
Time frame: These data will be collected at baseline only.
Abdominal and back muscle strength .
Time frame: These data will be collected at baseline only.
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 3 Jun 2019.
- Background: PubMed 16181938Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.
- Background: PubMed 29097026Sahrmann S, Azevedo DC, Dillen LV. Diagnosis and treatment of movement system impairment syndromes. Braz J Phys Ther. 2017 Nov-Dec;21(6):391-399. doi: 10.1016/j.bjpt.2017.08.001. Epub 2017 Sep 27.
- Background: PubMed 26240711Jandre Reis FJ, Macedo AR. Influence of Hamstring Tightness in Pelvic, Lumbar and Trunk Range of Motion in Low Back Pain and Asymptomatic Volunteers during Forward Bending. Asian Spine J. 2015 Aug;9(4):535-40. doi: 10.4184/asj.2015.9.4.535. Epub 2015 Jul 28.
- Derived from this study: PubMed 32339943Wattananon P, Prasertkul W, Sakulsriprasert P, Laskin JJ. Effect of increased relative stiffness of the lumbar spine on hamstring muscle stretching in individuals with a history of low back pain suspected to have a clinical lumbar instability: A randomized crossover design. Clin Biomech (Bristol). 2020 May;75:104996. doi: 10.1016/j.clinbiomech.2020.104996. Epub 2020 Apr 20.
- Individual participant dataSharing planned: Yes. The IPD of this study will be shared upon official request.
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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.
Peemongkon Wattananon, PhD principal investigator
Faculty of Physical Therapy, Mahidol 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 Lumbopelvic stiffening technique and Lumbopelvic relaxing technique in people with Back Pain and Instability Lumbar Spine, run by Mahidol University at 1 site in Thailand.
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 5 inclusion and 10 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 3 Jun 2019. 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 Thailand. 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?
Lumbar, pelvic, and lumbopelvic motions at baseline. (time frame: These data will be collected at baseline and immediately after intervention.). The study lists 4 primary outcomes in all. 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 NCT03787979, which also lists 4 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 3 Jun 2019.