Low Back PainOTCLBPNCT02983435
Osteopathic Treatment for Chronic Low Back Pain
A study testing G1 - Thrust manipulation and G2 - Muscle Energy in people with Low Back Pain and Osteopathic Manipulative Treatment, run by Universidade Norte do Paraná at 1 site in Brazil.
Trial summary
The relevance of this study is to determine the efficacy of two osteopathic techniques - Thrust Technique and Muscle Energy Technique (MET) - in improving of neuromuscular component of the trunk and clinical symptoms in adult workers with Chronic Low Back Pain (CLBP). Read more about this study
- Who is it for?
- Ages 35 to 55 years, men only
- Conditions the study is for
- Low Back Pain, Osteopathic Manipulative Treatment
- What is being tested?
- G1 - Thrust manipulation and G2 - Muscle Energy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2016to Apr 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 35 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Chronic low back pain at least for three months.
- Low back pain of unknown mechanical origin without irradiation to the lower limbs.
- Workers with chronic low back pain at least three months.
- Do not be participating in rehabilitation programs.
- Do not have practiced regular physical activity in the past 3 months.
Who cannot join
- Manual therapy treatment in the past 90 days.
- Discal herniation diagnosis.
- Lumbar radiculopathy and / or nerve root compression.
- Lumbar stenosis.
- Lumbar surgery.
- Nerve root entrapment.
Show all 15Show fewer
- Neurological and endocrine.
- Osteoporosis.
- Rheumatoid arthritis.
- Spinal osteomyelitis.
- Spondylolysis.
- Spondylolisthesis.
- Tumors.
- Vertebral fracture.
- No current sports or treatment in Physiotherapy, Pilates Method or Manual Therapy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Functional Assessment and Human Motor Performance (LAFUP)
Londrina, Paraná, 86041-120
About this study
Official title: Comparison Between Two Osteopathic Techniques for Chronic Low Back Pain Treatment: a Randomized Crossover Trial.
The relevance of this study is to determine the efficacy of two osteopathic techniques - Thrust Technique and Muscle Energy Technique (MET) - in improving of neuromuscular component of the trunk and clinical symptoms in adult workers with Chronic Low Back Pain (CLBP). Few studies have investigated and compared the physiological responses of these techniques quantitatively, and no published study has compared their effects in low back pain subjects in terms of symptoms, postural balance and muscle activation. The main outcomes will be computed by electromyography measurement so that to assess the trunk neuromuscular activation pattern as well as by force platform parameters for determining of postural control. Clinical symptoms such as pain intensity, perception of disability and fear and avoidance will also be computed.
This is the first study to compare these two osteopathic techniques using the main biological outcomes related to trunk neuromuscular function.
Read the detailed description
The purpose of this study is to assess the efficacy of two osteopathic techniques (Thrust and MET) on CLBP adult workers treatment.
A total of 15 male participants with chronic low back pain, volunteers, active workers aged from 35 to 55 years (in aging process) will be recruited by convenience from the community local. All participants will sign an informed consent form approved by the North of Parana University Ethics Committee for Research on Human Subjects. The intervention will follow the CONSORT recommendations for randomized controlled trials. All baseline testing and evaluation will be performed by a blinded evaluator to the study intervention. The sample will be randomized in two groups from crossover design: Group #1), which will receive the Thrust technique applied at the level of dysfunction; and Group #2, which will receive the Muscle Energy Technique, also applied at the level of dysfunction. The allocation will be printed in cards by sequentially numbered in opaque envelopes.
The treatment (intervention) will occur in 2 phases of 3 weeks each one. The participants will receive only one of techniques in each phase, and after one rest week (washout) they will receive the other technique (crossover), totaling 7 weeks. In this study, both techniques will be applied at the lumbar vertebral level that present the dysfunction which will be diagnosed in the specific evaluation, performed by two specialized physiotherapists in osteopathy. Before and after the manipulation (with Thrust or MET) all participants will be evaluated in 2 tasks - bipedal without load and bipedal with load (10% of body mass) - on the force platform. Parallel to the tasks, the recording of the measurements of EMG surface will be computed to determine the pattern of the trunk neuromuscular activation in amplitude of the RMS signal as well as muscle fatigue through the median frequency parameters.
Before performing the tasks on the force platform, a maximum voluntary isometric contraction will be performed for the back (paravertebral) and abdominal (rectus) muscles in order to normalize the signal EMG for determining of the level muscular activity during each task (with or without load). After the intervention, the immediate and final revaluations will include all the used measures in the initial evaluation, such as muscle activation of trunk (EMG), balance (force platform), and clinical symptoms of pain (Visual Analogue Scale and McGill Short Questionnaire), psychosomatic factors (Fear and Avoidance Believe Questionnaire) and disability (Roland Morris Questionnaire).
For the analysis a two-way ANOVA will be used for each dependent variable to compare the two groups (G1 versus G2) in both situations (pre and post-immediate, and after 15 days) in the clinical measurements, postural balance and EMG. The size effect also will be computed to determine the rate of the changes observed.
- Conditions
- Low Back Pain, Osteopathic Manipulative Treatment
- Being tested
- G1 - Thrust manipulation, G2 - Muscle Energy
- Keywords
- Osteopathic Treatment, Postural control, Neuromuscular activation, Physiotherapy
- 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.
G1 - Thrust manipulationOther
Osteopathic manipulation with Thrust technique. The Group 1 (G1) will receive the Thrust technique applied at the level of dysfunction. Subject in lateral decubitus, with one lower limb extended and the other in flexion, to the level of the targeted vertebra; upper trunk rotated back until the same vertebra; at the end of the range of movement will be applied the high speed and low amplitude impulse (Thrust).
G2 - Muscle EnergyOther
Osteopathic manipulation with Muscle Energy technique. The Group 2 (G2) will receive the Muscle Energy technique applied at the level of dysfunction. Subject in lateral decubitus, with the upper and lower trunk flexed until the target vertebra, and upper trunk rotated back to the level of the same vertebra; lumbar in lateral flexion (using the subject's feet) until the target vertebra. Following the command the subject will perform an isometric contraction of 3-5 seconds against the therapist's hand (pushing the hand towards the floor), repeated 3 times.
| Study group | Role | What they receive |
|---|---|---|
| G1 - Thrust manipulation | Experimental | G1 - Thrust manipulation is an osteopathic technique. The Group 1 (G1) will receive the Thrust technique applied at the level of dysfunction. Subject in lateral decubitus, with one lower limb extended and the other in flexion, to the level of the targeted vertebra; upper trunk rotated back until the same vertebra; at the end of the range of movement will be applied the high speed and low amplitude impulse (Thrust). Receives: Other: G1 - Thrust manipulation |
| G2 - Muscle Energy | Active comparator | G2 - Muscle Energy is a manual therapy technique based in muscular contraction and stretching. The Group 2 (G2) will receive the Muscle Energy technique applied at the level of dysfunction. Subject in lateral decubitus, with the upper and lower trunk flexed until the target vertebra, and upper trunk rotated back to the level of the same vertebra; lumbar in lateral flexion (using the subject's feet) until the target vertebra. Following the command the subject will perform an isometric contraction of 3-5 seconds against the therapist's hand (pushing the hand towards the floor), repeated 3 times. Receives: Other: G2 - Muscle Energy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography measurement - Root Mean Square (RMS)
EMG estimates, Root Mean Square: RMS (in microvolts unit: uV) will be computed to evaluate the back and abdominal activation during the functional task.
Measured: Change from baseline muscular activation at 3 weeks, in both phases
Secondary outcomes (2)
Electromyography measurement - Median Frequency (MF)
EMG estimates, Median Frequency: MF (in Hertz: Hz) will be computed to evaluate the back and abdominal activation during the functional task.
Measured: Change from baseline muscular activation at 3 weeks, in both phases
Force platform measurement
Force platform measurement during balance performance using centre of pressure measures to assess balance performance.
Measured: Change from baseline muscular activation at 3 weeks, in both phases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Norte do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubens Alexandre da Silva Jr, Universidade Norte do Paraná
- Investigators
- Rubens da Silva, PhD, Study director, Laboratory of Functional Assessment and Human Motor Performance (LAFUP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983435
- Sponsor's protocol ID
- rubens@unopar.br
- Acronym
- OTCLBP
- Status last verified
- Sep 2018
- First submitted
- 25 Nov 2016
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Licciardone JC, Minotti DE, Gatchel RJ, Kearns CM, Singh KP. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial. Ann Fam Med. 2013 Mar-Apr;11(2):122-9. doi: 10.1370/afm.1468.
PubMed 23508598Haas M, Vavrek D, Peterson D, Polissar N, Neradilek MB. Dose-response and efficacy of spinal manipulation for care of chronic low back pain: a randomized controlled trial. Spine J. 2014 Jul 1;14(7):1106-16. doi: 10.1016/j.spinee.2013.07.468. Epub 2013 Oct 16.
PubMed 24139233Wilder DG, Vining RD, Pohlman KA, Meeker WC, Xia T, Devocht JW, Gudavalli RM, Long CR, Owens EF, Goertz CM. Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial. Trials. 2011 Jun 28;12:161. doi: 10.1186/1745-6215-12-161.
PubMed 21708042Cleland JA, Fritz JM, Childs JD, Kulig K. Comparison of the effectiveness of three manual physical therapy techniques in a subgroup of patients with low back pain who satisfy a clinical prediction rule: study protocol of a randomized clinical trial [NCT00257998]. BMC Musculoskelet Disord. 2006 Feb 10;7:11. doi: 10.1186/1471-2474-7-11.
PubMed 16472379da Silva RA Jr, Arsenault AB, Gravel D, Lariviere C, de Oliveira E Jr. Back muscle strength and fatigue in healthy and chronic low back pain subjects: a comparative study of 3 assessment protocols. Arch Phys Med Rehabil. 2005 Apr;86(4):722-9. doi: 10.1016/j.apmr.2004.08.007.
PubMed 15827924Lariviere C, Gagnon D, Loisel P. The comparison of trunk muscles EMG activation between subjects with and without chronic low back pain during flexion-extension and lateral bending tasks. J Electromyogr Kinesiol. 2000 Apr;10(2):79-91. doi: 10.1016/s1050-6411(99)00027-9.
PubMed 10699556
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Osteopathic Techniques for Chronic Low Back Pain Treatment: a Randomized Crossover Trial.
- ClinicalTrials.gov ID
- NCT02983435
- Acronym / sponsor ID
- OTCLBP / rubens@unopar.br
- Conditions
- Low Back Pain, Osteopathic Manipulative Treatment
- Keywords
- Osteopathic Treatment, Postural control, Neuromuscular activation, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidade Norte do ParanáUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 6 Dec 2016 (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 relevance of this study is to determine the efficacy of two osteopathic techniques - Thrust Technique and Muscle Energy Technique (MET) - in improving of neuromuscular component of the trunk and clinical symptoms in adult workers with Chronic Low Back Pain (CLBP). Few studies have investigated and compared the physiological responses of these techniques quantitatively, and no published study has compared their effects in low back pain subjects in terms of symptoms, postural balance and muscle activation. The main outcomes will be computed by electromyography measurement so that to assess the trunk neuromuscular activation pattern as well as by force platform parameters for determining of postural control. Clinical symptoms such as pain intensity, perception of disability and fear and avoidance will also be computed.
This is the first study to compare these two osteopathic techniques using the main biological outcomes related to trunk neuromuscular function.
Detailed description
The purpose of this study is to assess the efficacy of two osteopathic techniques (Thrust and MET) on CLBP adult workers treatment.
A total of 15 male participants with chronic low back pain, volunteers, active workers aged from 35 to 55 years (in aging process) will be recruited by convenience from the community local. All participants will sign an informed consent form approved by the North of Parana University Ethics Committee for Research on Human Subjects. The intervention will follow the CONSORT recommendations for randomized controlled trials. All baseline testing and evaluation will be performed by a blinded evaluator to the study intervention. The sample will be randomized in two groups from crossover design: Group #1), which will receive the Thrust technique applied at the level of dysfunction; and Group #2, which will receive the Muscle Energy Technique, also applied at the level of dysfunction. The allocation will be printed in cards by sequentially numbered in opaque envelopes.
The treatment (intervention) will occur in 2 phases of 3 weeks each one. The participants will receive only one of techniques in each phase, and after one rest week (washout) they will receive the other technique (crossover), totaling 7 weeks. In this study, both techniques will be applied at the lumbar vertebral level that present the dysfunction which will be diagnosed in the specific evaluation, performed by two specialized physiotherapists in osteopathy. Before and after the manipulation (with Thrust or MET) all participants will be evaluated in 2 tasks - bipedal without load and bipedal with load (10% of body mass) - on the force platform. Parallel to the tasks, the recording of the measurements of EMG surface will be computed to determine the pattern of the trunk neuromuscular activation in amplitude of the RMS signal as well as muscle fatigue through the median frequency parameters.
Before performing the tasks on the force platform, a maximum voluntary isometric contraction will be performed for the back (paravertebral) and abdominal (rectus) muscles in order to normalize the signal EMG for determining of the level muscular activity during each task (with or without load). After the intervention, the immediate and final revaluations will include all the used measures in the initial evaluation, such as muscle activation of trunk (EMG), balance (force platform), and clinical symptoms of pain (Visual Analogue Scale and McGill Short Questionnaire), psychosomatic factors (Fear and Avoidance Believe Questionnaire) and disability (Roland Morris Questionnaire).
For the analysis a two-way ANOVA will be used for each dependent variable to compare the two groups (G1 versus G2) in both situations (pre and post-immediate, and after 15 days) in the clinical measurements, postural balance and EMG. The size effect also will be computed to determine the rate of the changes observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G1 - Thrust manipulation | Experimental | Other: G1 - Thrust manipulationG1 - Thrust manipulation is an osteopathic technique. The Group 1 (G1) will receive the Thrust technique applied at the level of dysfunction. Subject in lateral decubitus, with one lower limb extended and the other in flexion, to the level of the targeted vertebra; upper trunk rotated back until the same vertebra; at the end of the range of movement will be applied the high speed and low amplitude impulse (Thrust). |
| G2 - Muscle Energy | Active comparator | Other: G2 - Muscle EnergyG2 - Muscle Energy is a manual therapy technique based in muscular contraction and stretching. The Group 2 (G2) will receive the Muscle Energy technique applied at the level of dysfunction. Subject in lateral decubitus, with the upper and lower trunk flexed until the target vertebra, and upper trunk rotated back to the level of the same vertebra; lumbar in lateral flexion (using the subject's feet) until the target vertebra. Following the command the subject will perform an isometric contraction of 3-5 seconds against the therapist's hand (pushing the hand towards the floor), repeated 3 times. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chronic low back pain at least for three months.
- Low back pain of unknown mechanical origin without irradiation to the lower limbs.
- Workers with chronic low back pain at least three months.
- Do not be participating in rehabilitation programs.
- Do not have practiced regular physical activity in the past 3 months.
Key exclusion criteria (15 listed)
- Manual therapy treatment in the past 90 days.
- Discal herniation diagnosis.
- Lumbar radiculopathy and / or nerve root compression.
- Lumbar stenosis.
- Lumbar surgery.
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 |
|---|---|---|
| G1 - Thrust manipulationOsteopathic manipulation with Thrust technique. The Group 1 (G1) will receive the Thrust technique applied at the level of dysfunction. Subject in lateral decubitus, with one lower limb extended and the other in flexion, to the level of the targeted vertebra; upper trunk rotated back until the same vertebra; at the end of the range of movement will be applied the high speed and low amplitude impulse (Thrust). | Other | G1 - Thrust manipulation |
| G2 - Muscle EnergyOsteopathic manipulation with Muscle Energy technique. The Group 2 (G2) will receive the Muscle Energy technique applied at the level of dysfunction. Subject in lateral decubitus, with the upper and lower trunk flexed until the target vertebra, and upper trunk rotated back to the level of the same vertebra; lumbar in lateral flexion (using the subject's feet) until the target vertebra. Following the command the subject will perform an isometric contraction of 3-5 seconds against the therapist's hand (pushing the hand towards the floor), repeated 3 times. | Other | G2 - Muscle Energy |
Primary outcome
Electromyography measurement - Root Mean Square (RMS)
Time frame: Change from baseline muscular activation at 3 weeks, in both phases
EMG estimates, Root Mean Square: RMS (in microvolts unit: uV) will be computed to evaluate the back and abdominal activation during the functional task.
2 secondary outcomes
Electromyography measurement - Median Frequency (MF)
Time frame: Change from baseline muscular activation at 3 weeks, in both phases
Force platform measurement
Time frame: Change from baseline muscular activation at 3 weeks, in both phases
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 7 Sep 2018.
- Background: PubMed 23508598Licciardone JC, Minotti DE, Gatchel RJ, Kearns CM, Singh KP. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial. Ann Fam Med. 2013 Mar-Apr;11(2):122-9. doi: 10.1370/afm.1468.
- Background: PubMed 24139233Haas M, Vavrek D, Peterson D, Polissar N, Neradilek MB. Dose-response and efficacy of spinal manipulation for care of chronic low back pain: a randomized controlled trial. Spine J. 2014 Jul 1;14(7):1106-16. doi: 10.1016/j.spinee.2013.07.468. Epub 2013 Oct 16.
- Background: PubMed 21708042Wilder DG, Vining RD, Pohlman KA, Meeker WC, Xia T, Devocht JW, Gudavalli RM, Long CR, Owens EF, Goertz CM. Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial. Trials. 2011 Jun 28;12:161. doi: 10.1186/1745-6215-12-161.
- Background: PubMed 16472379Cleland JA, Fritz JM, Childs JD, Kulig K. Comparison of the effectiveness of three manual physical therapy techniques in a subgroup of patients with low back pain who satisfy a clinical prediction rule: study protocol of a randomized clinical trial [NCT00257998]. BMC Musculoskelet Disord. 2006 Feb 10;7:11. doi: 10.1186/1471-2474-7-11.
- Background: PubMed 15827924da Silva RA Jr, Arsenault AB, Gravel D, Lariviere C, de Oliveira E Jr. Back muscle strength and fatigue in healthy and chronic low back pain subjects: a comparative study of 3 assessment protocols. Arch Phys Med Rehabil. 2005 Apr;86(4):722-9. doi: 10.1016/j.apmr.2004.08.007.
- Background: PubMed 10699556Lariviere C, Gagnon D, Loisel P. The comparison of trunk muscles EMG activation between subjects with and without chronic low back pain during flexion-extension and lateral bending tasks. J Electromyogr Kinesiol. 2000 Apr;10(2):79-91. doi: 10.1016/s1050-6411(99)00027-9.
- 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.
Rubens da Silva, PhD study director
Laboratory of Functional Assessment and Human Motor Performance (LAFUP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G1 - Thrust manipulation and G2 - Muscle Energy in people with Low Back Pain and Osteopathic Manipulative Treatment, run by Universidade Norte do Paraná at 1 site in Brazil.
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 15 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 7 Sep 2018. 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 Brazil. 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?
Electromyography measurement - Root Mean Square (RMS) (time frame: Change from baseline muscular activation at 3 weeks, in both phases). 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 NCT02983435, which also lists 6 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 7 Sep 2018.