Chronic Low Back PainNCT01861418
Effects of Lumbopelvic Manipulation on Neuromuscular Activity of Back & Hip Muscles in Adults With Chronic Low Back Pain
A study testing Lumbopelvic Manipulation in people with Chronic Low Back Pain, run by Texas Woman's University at 1 site in United States.
Trial summary
The purposes of this study are: 1. To examine the within-day and between-day test-retest reliability of a testing protocol measuring the back and hip muscles fatigability using EMG median frequency 2. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Lumbopelvic Manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jul 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects without any history of back problems
- Subjects without any known pathology.
- Participants should be between the age of 20 to 60 years.
- Have had complaints of chronic low back pain for at least three months.
Who cannot join
- Any serious spinal condition such as tumor, fracture, or infection,
- Signs of nerve root compression (i.e. straight leg- raise ≤ 45° or diminished reflexes, sensation or lower extremity strength),
- Structural deformity,
- Spondylolithesis ,
- Ankylosing spondylitis
- Spinal stenosis,
Show all 19Show fewer
- Osteoporosis,
- Previous surgery to the back or the hip, and
- Current pregnancy.
- Subjects with Chronic low back pain for both the reliability and the manipulation phases:
- Any serious spinal condition such as tumor, fracture, or infection,
- Signs of nerve root compression (i.e. straight leg- raise ≤ 45° or diminished reflexes, sensation or lower extremity strength),
- Structural deformity,
- Spondylolithesis ,
- Ankylosing spondylitis
- Spinal stenosis,
- Osteoporosis,
- Previous surgery to the back or the hip, and
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Lumbopelvic Manipulation on Neuromuscular Activity of Back and Hip Muscles in Adults With Chronic Low Back Pain
The purposes of this study are:
- To examine the within-day and between-day test-retest reliability of a testing protocol measuring the back and hip muscles fatigability using EMG median frequency
- To examine the immediate and the carry-over effects of the lumbopelvic manipulation on the EMG median frequency of the lumbar multifidus (MULT), gluteus medius (GMED) and gluteus maximus (GMAX) muscles in patients with chronic low back pain (CLBP)
- To compare the fatigability levels of the MULT, GMED and GMAX muscles by measuring the EMG median frequency between the participants who will receive lumbopelvic manipulation.
Read more
The research hypotheses are:
- The testing protocol using EMG median frequency as a fatigue indicator for MULT,GMED and GMAX muscles will have good (ICC ≥ 0.80) within-day and between-day test-retest reliability.
- The fatigability level of the MULT, GMED and GMAX muscles will significantly decrease immediately after the lumbopelvic manipulation and will be maintained over two to four days following the manipulation.
- The fatigability of the MULT, GMED and GMAX muscles will significantly decrease after the intervention in the manipulation group while no change will occur in the placebo group.
- Conditions
- Chronic Low Back Pain
- Being tested
- Lumbopelvic Manipulation, Sham manipulation
- Keywords
- chronic low back pain, low back pain, lumbopelvic manipulation, Chicago manipulation, EMG median frequency, electromyography, reliability
- 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.
Lumbopelvic ManipulationOther
Also called Chicago Manipulation Technique
Participant will lie in supine position. The treating investigator (TI) will stand on opposite side of low back pain. Participant will clasp his/her hand behind the neck. TI will side bend participant's spine towards non-painful side. TI will reach through participant's hands and perform spinal rotation away from painful side. TI's other hand will be placed over anterior superior iliac spine (ASIS) of painful side. TI will take up the slack and maintain pressure on the ASIS for 5-10 seconds and ask the participant whether he/she can tolerate the pressure. If participant can tolerate the pressure for at least 5 seconds, verbal permission will be obtained from participant and TI will proceed and apply a high-velocity low-amplitude posterior thrust force over the ASIS.
Sham manipulationOther
Each participant will be asked to lie in a supine position. The treating investigator will stand on the opposite side of the low back pain. Then, the participant will be asked to clasp his/her hand behind the neck. The treating investigator will side bend the participant's spine towards the non-painful side to mid-range. The treating investigator will reach through the participant's hands and perform a spinal rotation away from the painful side to the mid-range. The treating investigator's other hand will be placed over the anterior superior iliac spine (ASIS) of the painful side.
| Study group | Role | What they receive |
|---|---|---|
| Sham manipulation | Placebo comparator | Each participant will lie in a supine position. The treating investigator (TI) will stand on the opposite side of the low back pain. Then, the participant will be asked to clasp his/her hand behind the neck. The TI will side bend the participant's spine towards the non-painful side, reach through the participant's hands and perform a spinal rotation away from the painful side. The TIs other hand will be placed over the anterior superior iliac spine (ASIS) of the painful side. Lastly, the TI will take up the slack and maintain the pressure on the ASIS for 5-10 seconds and ask the participant whether he/she can tolerate the pressure. If the participant can tolerate the pressure for at least 5 seconds. Then, the subjects will be re-positioned to the starting position. Receives: Other: Sham manipulation |
| Lumbopelvic Manipulation, Chicago | Experimental | Each participant will lie in supine position. The treating investigator (TI) will stand opposite of the low back pain. Participant will clasp his/her hand behind the neck. TI will side bend the participant's spine toward non-painful side, reach through participant's hands and perform a spinal rotation away from the painful side. TI's other hand will be placed over the anterior superior iliac spine (ASIS) of the painful side. The TI will take up the slack and maintain pressure on the ASIS for 5-10 seconds and ask participant whether he/she can tolerate the pressure. If participant can tolerate the pressure for at least 5 seconds, verbal permission will be obtained from the participant and the TI will proceed and apply a high-velocity low-amplitude posterior thrust force over the ASIS. Receives: Other: Lumbopelvic Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Change in Muscles Endurance
electromyographic (EMG) median frequency will be used to determine the endurance of the gluteus maximums, gluteus medius and the lumbar multifidus muscles. The EMG median frequency will be measured in Hertz (Hz).
Measured: Baseline, Immediately, 15-minutes, 30-minutes, and two to four days after the intervention
Secondary outcomes (1)
Amount of Change in Pain Level
Pain Visual Analogue Scale (VAS) will be used in this study. Participants will be asked to rate their pain level on a 10-cm horizontal line which is marked on the left end "No pain" and on the right end "Extreme pain". Then, the pain level for a specific participant will be determined by measuring the line from the "No pain" end to the mark placed by the participant.
Measured: Baseline, immediately, 15-minutes, 30-minutes, and two to four days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad A Almadan, PhD Student, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861418
- Sponsor's protocol ID
- TexasWU
- Status last verified
- Oct 2016
- First submitted
- 20 May 2013
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lumbopelvic Manipulation on Neuromuscular Activity of Back and Hip Muscles in Adults With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01861418
- Acronym / sponsor ID
- TexasWU
- Conditions
- Chronic Low Back Pain
- Keywords
- chronic low back pain, low back pain, lumbopelvic manipulation, Chicago manipulation, EMG median frequency, electromyography, reliability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 23 May 2013 (estimated)
- 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 purposes of this study are:
- To examine the within-day and between-day test-retest reliability of a testing protocol measuring the back and hip muscles fatigability using EMG median frequency
- To examine the immediate and the carry-over effects of the lumbopelvic manipulation on the EMG median frequency of the lumbar multifidus (MULT), gluteus medius (GMED) and gluteus maximus (GMAX) muscles in patients with chronic low back pain (CLBP)
- To compare the fatigability levels of the MULT, GMED and GMAX muscles by measuring the EMG median frequency between the participants who will receive lumbopelvic manipulation.
The research hypotheses are:
- The testing protocol using EMG median frequency as a fatigue indicator for MULT,GMED and GMAX muscles will have good (ICC ≥ 0.80) within-day and between-day test-retest reliability.
- The fatigability level of the MULT, GMED and GMAX muscles will significantly decrease immediately after the lumbopelvic manipulation and will be maintained over two to four days following the manipulation.
- The fatigability of the MULT, GMED and GMAX muscles will significantly decrease after the intervention in the manipulation group while no change will occur in the placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham manipulation | Placebo comparator | Other: Sham manipulationEach participant will lie in a supine position. The treating investigator (TI) will stand on the opposite side of the low back pain. Then, the participant will be asked to clasp his/her hand behind the neck. The TI will side bend the participant's spine towards the non-painful side, reach through the participant's hands and perform a spinal rotation away from the painful side. The TIs other hand will be placed over the anterior superior iliac spine (ASIS) of the painful side. Lastly, the TI will take up the slack and maintain the pressure on the ASIS for 5-10 seconds and ask the participant whether he/she can tolerate the pressure. If the participant can tolerate the pressure for at least 5 seconds. Then, the subjects will be re-positioned to the starting position. |
| Lumbopelvic Manipulation, Chicago | Experimental | Other: Lumbopelvic ManipulationEach participant will lie in supine position. The treating investigator (TI) will stand opposite of the low back pain. Participant will clasp his/her hand behind the neck. TI will side bend the participant's spine toward non-painful side, reach through participant's hands and perform a spinal rotation away from the painful side. TI's other hand will be placed over the anterior superior iliac spine (ASIS) of the painful side. The TI will take up the slack and maintain pressure on the ASIS for 5-10 seconds and ask participant whether he/she can tolerate the pressure. If participant can tolerate the pressure for at least 5 seconds, verbal permission will be obtained from the participant and the TI will proceed and apply a high-velocity low-amplitude posterior thrust force over the ASIS. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects without any history of back problems
- Subjects without any known pathology.
- Participants should be between the age of 20 to 60 years.
- Have had complaints of chronic low back pain for at least three months.
Key exclusion criteria (19 listed)
- Any serious spinal condition such as tumor, fracture, or infection,
- Signs of nerve root compression (i.e. straight leg- raise ≤ 45° or diminished reflexes, sensation or lower extremity strength),
- Structural deformity,
- Spondylolithesis ,
- Ankylosing spondylitis
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 ManipulationAlso: Chicago Manipulation TechniqueParticipant will lie in supine position. The treating investigator (TI) will stand on opposite side of low back pain. Participant will clasp his/her hand behind the neck. TI will side bend participant's spine towards non-painful side. TI will reach through participant's hands and perform spinal rotation away from painful side. TI's other hand will be placed over anterior superior iliac spine (ASIS) of painful side. TI will take up the slack and maintain pressure on the ASIS for 5-10 seconds and ask the participant whether he/she can tolerate the pressure. If participant can tolerate the pressure for at least 5 seconds, verbal permission will be obtained from participant and TI will proceed and apply a high-velocity low-amplitude posterior thrust force over the ASIS. | Other | Lumbopelvic Manipulation, Chicago |
| Sham manipulationEach participant will be asked to lie in a supine position. The treating investigator will stand on the opposite side of the low back pain. Then, the participant will be asked to clasp his/her hand behind the neck. The treating investigator will side bend the participant's spine towards the non-painful side to mid-range. The treating investigator will reach through the participant's hands and perform a spinal rotation away from the painful side to the mid-range. The treating investigator's other hand will be placed over the anterior superior iliac spine (ASIS) of the painful side. | Other | Sham manipulation |
Primary outcome
Amount of Change in Muscles Endurance
Time frame: Baseline, Immediately, 15-minutes, 30-minutes, and two to four days after the intervention
electromyographic (EMG) median frequency will be used to determine the endurance of the gluteus maximums, gluteus medius and the lumbar multifidus muscles. The EMG median frequency will be measured in Hertz (Hz).
1 secondary outcome
Amount of Change in Pain Level
Time frame: Baseline, immediately, 15-minutes, 30-minutes, and two to four days after the intervention
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 12 Oct 2017.
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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.
Mohammad A Almadan, PhD Student principal investigator
Texas Woman's 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 Manipulation in people with Chronic Low Back Pain, run by Texas Woman's University 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 19 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 12 Oct 2017. 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. Some participants in this study may receive a placebo. 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?
Amount of Change in Muscles Endurance (time frame: Baseline, Immediately, 15-minutes, 30-minutes, and two to four days after the intervention). 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 12 Oct 2017.