Low Back Pain, MechanicalNCT06150625
Pragmatically Applied Orthopedic Manual Therapy and Dry Needling for Low Back Pain.
A study testing Orthopedic Manaual Therapy, Dry Needling and Home exercise program in people with Low Back Pain, Mechanical, run by Youngstown State University.
Trial summary
Both orthopedic manual therapy (OMT) and dry needling (DN) have been shown to be effective at reducing pain and disability for individuals with low back pain (LBP). It is unclear if one intervention, or in combination with one another, is more effective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Orthopedic Manaual Therapy, Dry Needling and Home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are 18 years of age or older, present with LBP and a pain score of > or = 3/10
Who cannot join
- Patients will be excluded if they present with a contraindication to either treatment (malignancy, fracture, myelopathy, osteoporosis, etc.), have a prior surgical history involving the lumbar spine, present with spinal nerve root compression (2 or more neurological findings that includes myotome weakness, dermatomal sensory loss, and/or deep tendon reflexive changes), are seeking litigation, or are receiving other forms of conservative care.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison Between Pragmatically Applied Orthopedic Manual Therapy and Dry Needling for Low Back Pain.
Both orthopedic manual therapy (OMT) and dry needling (DN) have been shown to be effective at reducing pain and disability for individuals with low back pain (LBP). It is unclear if one intervention, or in combination with one another, is more effective. The purpose of this randomized clinical trial is to determine the clinical effectiveness of OMT or DN alone compared with combined OMT + DN on pain and disability for patients with LBP. Both within and between group effects will be presented.
Patient factors such as; generalized anxiety disorder, depression, fear-avoidance behaviors, pain catastrophizing, and sleep-quality have negatively correlated with pain and disability outcomes in patients experiencing chronic LBP. Moreover, sleep deprivation and pain related fear of movement functionally can change a person's pain inhibitory pathways leading to hyeralgesia. These factors have been individually analyzed regarding their effects on pain related outcomes, which limits our understanding of how clustering patient factors might affect recovery. A secondary aim will involve determining the relationship between patient factors and clinical outcomes for individuals with LBP who receive DN and/or manual therapy.
Read the detailed description
Low back pain (LBP) is a common disorder, (GBD,2016) placing a tremendous financial burden on the health care and occupational systems. (Freburg,2009) The etiology and influences to chronic LBP remains unknown due to multiple interacting factors involving pain, disability, psychosocial, and psychological factors. While the search for effective therapies has been ongoing in clinical trials, the optimal management strategies remain elusive due to inconsistent findings in randomized clinical trials (RCT) and systematic reviews. (Bussieres,2018; Coulter, 2018;Kamper, 2015)
Orthopedic manual therapy is routinely used to assist patients with LBP manage their symptoms. (George, 2021) Mechanisms identified in pre-clinical studies involve local, segmental, and systemic neurophysiological changes helping reduce pain.(Bialosky,2018) Two popular forms of orthopedic manual therapy are spinal manipulation/mobilization therapy and dry needling (DN). While these treatments share mechanisms of action, DN also creates a physiological lesion resulting in mechanical disruption of connective tissue to deeper structures. Clinical Practice Guidelines recommend both OMT and DN be incorporated as part of a multimodal treatment plan.(George,2021) It is unknown if these treatments combined produce larger treatment effects than when they are applied individually. While this treatment combination has been investigated for other musculoskeletal conditions (Dunning, 2021a; Dunning, 2021b; González-Iglesias,2013; Gattie, 2021), it has not been studied for LBP.
Patient Factors that Influence Outcomes Patient factors such as generalized anxiety disorder, depression, fear-avoidance behaviors, pain catastrophizing, and sleep-quality have negatively correlated with pain and disability outcomes in patients experiencing chronic LBP. (Alhowimel,2018) A recent multimodal metanalysis involving patients with depressive/anxiety disorders with chronic pain observed disorder specific neurological changes on functional MRI, exploiting neuro-behavioral mechanisms. (Brandl 2022) Moreover, sleep deprivation and pain related fear of movement functionally can change a person's pain inhibitory pathways leading to hyeralgesia. (Finan 2013; Meier, 2017) These factors have been individually analyzed regarding their effects on pain related outcomes, which limits our understanding of how clustering patient factors might affect recovery. We hypothesize that certain combinations of patient factors will correlate with those patients with chronic LBP who were less likely to experience a clinically meaningful change in pain and disability.
Statement of the Problems
Problem 1: The most effective conservative management strategies for patients with LBP remains unknown. Manual therapy is routinely used in clinical practice and recommended in Clinical Practice Guidelines, including OMT and DN. It is unknown if a pragmatically applied OMT combined with DN produces larger treatment effects than a pragmatically applied SMT alone for patients with LBP.
Problem 2: Patient factors such as psychological and psychosocial factors, patient recovery expectations, and patient treatment preferences have all demonstrated the ability to influence clinical outcomes in patients with LBP. Currently it is not understood how the presence of multiple patient variables combine to interact with patient outcomes.
Purpose Statement The purpose of this randomized clinical trial is to determine the clinical effectiveness of OMT or DN alone compared with OMT and DN on pain and disability for patients with LBP. Both within and between group effects will be presented. Our hypothesis is that individuals treated with both OMT and DN will experience greater changes in pain and disability compared with those who receive either treatment individually. We also anticipate the presence of patient factors known to influence pain will negatively correlate with patient outcomes and certain combinations of these patient factors may have a stronger influence on clinical outcomes.
Statement of Research Objectives
Specific Aim 1: Determine the comparative effectiveness of pragmatically applied OMT with DN compared to OMT or DN alone for patients with LBP and disability.
Specific Aim 2: Determine the relationship between patient factors and clinical outcomes for individuals with LBP who receive DN and/or OMT.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Orthopedic Manaual Therapy, Dry Needling, Home exercise program, Patient education
- Keywords
- Low back pain, manual therapy, dry needling
- 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.
Orthopedic Manaual TherapyOther
Can include either spinal mobilizations or spinal manipulation therapy targeting the stiff or symptomatic level of the lumbar spine. Various types of mobilization or manipulation may be used based on the therapists clinical reasoning. The therapist will determine which technique and dosage parameters for each subject based on individual patient clinical data. Common mobilizations techniques involve gently and repeatedly applying pressure over different parts of the patient's spine that is associated with their symptoms. For a manipulation, the patient will be positioned in side-lying position. The therapist will then position the patient further to target the symptomatic level. The patient is asked to take a deep breathe in and out. The therapist will slowly add pressure through the trunk and apply a fast but small thrust motion toward the table.
Dry NeedlingOther
dry needling both sides of the symptomatic level(s) of the lumbar spine as well as needling other areas in the lower extremity and pelvis based on the results of their clinical evaluation and/or the subjects presenting symptoms. Dry needling involves the insertion of a monofilament needle (nothing is injected) into symptomatic soft tissue. The therapist will determine which technique and dosage parameters for each subject based on individual patient clinical data.
Home exercise programOther
5 exercises will be selected from 10 options intended to reinforce the improvements made from treatment.
Patient educationOther
Patient education on the low back condition, advice to stay active, and home exercise performance.
| Study group | Role | What they receive |
|---|---|---|
| Orthopedic Manual Therapy | Active comparator | Participants randomized to this arm will receive clinician-selected orthopedic manual therapy targeting the joints of the low back. Selected techniques can involve joint mobilizations or spinal manipulation. The dosage parameters will be determined by the clinician.
Patient Education Patients will receive education regarding their low back pain, advice to stay active, proper performance of their home exercise program.
Home exercise program The program will consist of 10 exercises which the clinician will select 5 they feel would be most beneficial to the patient. These can include aerobic, general strengthening, directional preference, or neural self-mobilizations. Receives: Other: Orthopedic Manaual Therapy; Other: Home exercise program; Other: Patient education |
| Dry Needling | Active comparator | Participants randomized to this arm will receive dry needling to the low back and lower extremity while being applied based on clinician-selected areas of symptomatic soft tissue. The dosage parameters will be determined by the clinician.
Patient Education Patients will receive education regarding their low back pain, advice to stay active, proper performance of their home exercise program.
Home exercise program The program will consist of 10 exercises which the clinician will select 5 they feel would be most beneficial to the patient. These can include aerobic, general strengthening, directional preference, or neural self-mobilizations. Receives: Other: Dry Needling; Other: Home exercise program; Other: Patient education |
| Orthopedic Manual Therapy and Dry needling | Experimental | Participants randomized to this arm will receive dry needling to the lumbar spine and lower extremity based on clinician-selected areas of symptomatic soft-tissue and or orthopedic manual therapy targeting the joints of the low back.
Patient Education Patients will receive education regarding their low back pain, advice to stay active, proper performance of their home exercise program.
Home exercise program The program will consist of 10 exercises which the clinician will select 5 they feel would be most beneficial to the patient. These can include aerobic, general strengthening, directional preference, or neural self-mobilizations. Receives: Other: Orthopedic Manaual Therapy; Other: Dry Needling; Other: Home exercise program; Other: Patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS-29.2
Questionnaire that assesses 7 domains with 4 questions with an additional pain intensity numeric rating scale (NPRS). The PROMIS measures have been tested and validated in large reference populations making them suitable for research on different conditions.
Measured: Baseline, 1 week, 1 month, and 6 months
Secondary outcomes (3)
Global Rating of Change
Questionnaire that assesses the global degree of change the patient perceives since the start of care.
The patient rates their change from 0 (no change) to +7 (A Very Great Deal Better) to -7 (A Very Great Deal Worse)
Measured: 1 week, 1 month, and 6 months
Global Rating of Change for Medication Intake
Questionnaire that assesses the global degree of change in pain medication the patient experienced since the start of care. The patient rates their change in medications from 0 (no change) to +7 (A Very Great Deal Less) to -7 (A Very Great Deal More)
Measured: 1 week, 1 month, and 6 months
Health Care Utilization
Patients will report any providers they had to see after the completion of the study to 6 months for their low back problem.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
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 Low Back Pain, MechanicalStudies 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
- Model description
- The outcome assessor needing access to REDcap will be blinded the treatment group. The clinician providing treatment will be blinded to outcomes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Youngstown State University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150625
- Sponsor's protocol ID
- 2024-35
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rubinstein SM, de Zoete A, van Middelkoop M, Assendelft WJJ, de Boer MR, van Tulder MW. Benefits and harms of spinal manipulative therapy for the treatment of chronic low back pain: systematic review and meta-analysis of randomised controlled trials. BMJ. 2019 Mar 13;364:l689. doi: 10.1136/bmj.l689.
PubMed 30867144Hu HT, Gao H, Ma RJ, Zhao XF, Tian HF, Li L. Is dry needling effective for low back pain?: A systematic review and PRISMA-compliant meta-analysis. Medicine (Baltimore). 2018 Jun;97(26):e11225. doi: 10.1097/MD.0000000000011225.
PubMed 29952980Corp N, Mansell G, Stynes S, Wynne-Jones G, Morso L, Hill JC, van der Windt DA. Evidence-based treatment recommendations for neck and low back pain across Europe: A systematic review of guidelines. Eur J Pain. 2021 Feb;25(2):275-295. doi: 10.1002/ejp.1679. Epub 2020 Nov 12.
PubMed 33064878Owen PJ, Miller CT, Mundell NL, Verswijveren SJJM, Tagliaferri SD, Brisby H, Bowe SJ, Belavy DL. Which specific modes of exercise training are most effective for treating low back pain? Network meta-analysis. Br J Sports Med. 2020 Nov;54(21):1279-1287. doi: 10.1136/bjsports-2019-100886. Epub 2019 Oct 30.
PubMed 31666220
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Pragmatically Applied Orthopedic Manual Therapy and Dry Needling for Low Back Pain.
- ClinicalTrials.gov ID
- NCT06150625
- Acronym / sponsor ID
- 2024-35
- Conditions
- Low Back Pain, Mechanical
- Keywords
- Low back pain, manual therapy, dry needling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Youngstown State UniversityUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Nov 2023 (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.
Both orthopedic manual therapy (OMT) and dry needling (DN) have been shown to be effective at reducing pain and disability for individuals with low back pain (LBP). It is unclear if one intervention, or in combination with one another, is more effective. The purpose of this randomized clinical trial is to determine the clinical effectiveness of OMT or DN alone compared with combined OMT + DN on pain and disability for patients with LBP. Both within and between group effects will be presented.
Patient factors such as; generalized anxiety disorder, depression, fear-avoidance behaviors, pain catastrophizing, and sleep-quality have negatively correlated with pain and disability outcomes in patients experiencing chronic LBP. Moreover, sleep deprivation and pain related fear of movement functionally can change a person's pain inhibitory pathways leading to hyeralgesia. These factors have been individually analyzed regarding their effects on pain related outcomes, which limits our understanding of how clustering patient factors might affect recovery. A secondary aim will involve determining the relationship between patient factors and clinical outcomes for individuals with LBP who receive DN and/or manual therapy.
Detailed description
Low back pain (LBP) is a common disorder, (GBD,2016) placing a tremendous financial burden on the health care and occupational systems. (Freburg,2009) The etiology and influences to chronic LBP remains unknown due to multiple interacting factors involving pain, disability, psychosocial, and psychological factors. While the search for effective therapies has been ongoing in clinical trials, the optimal management strategies remain elusive due to inconsistent findings in randomized clinical trials (RCT) and systematic reviews. (Bussieres,2018; Coulter, 2018;Kamper, 2015)
Orthopedic manual therapy is routinely used to assist patients with LBP manage their symptoms. (George, 2021) Mechanisms identified in pre-clinical studies involve local, segmental, and systemic neurophysiological changes helping reduce pain.(Bialosky,2018) Two popular forms of orthopedic manual therapy are spinal manipulation/mobilization therapy and dry needling (DN). While these treatments share mechanisms of action, DN also creates a physiological lesion resulting in mechanical disruption of connective tissue to deeper structures. Clinical Practice Guidelines recommend both OMT and DN be incorporated as part of a multimodal treatment plan.(George,2021) It is unknown if these treatments combined produce larger treatment effects than when they are applied individually. While this treatment combination has been investigated for other musculoskeletal conditions (Dunning, 2021a; Dunning, 2021b; González-Iglesias,2013; Gattie, 2021), it has not been studied for LBP.
Patient Factors that Influence Outcomes Patient factors such as generalized anxiety disorder, depression, fear-avoidance behaviors, pain catastrophizing, and sleep-quality have negatively correlated with pain and disability outcomes in patients experiencing chronic LBP. (Alhowimel,2018) A recent multimodal metanalysis involving patients with depressive/anxiety disorders with chronic pain observed disorder specific neurological changes on functional MRI, exploiting neuro-behavioral mechanisms. (Brandl 2022) Moreover, sleep deprivation and pain related fear of movement functionally can change a person's pain inhibitory pathways leading to hyeralgesia. (Finan 2013; Meier, 2017) These factors have been individually analyzed regarding their effects on pain related outcomes, which limits our understanding of how clustering patient factors might affect recovery. We hypothesize that certain combinations of patient factors will correlate with those patients with chronic LBP who were less likely to experience a clinically meaningful change in pain and disability.
Statement of the Problems
Problem 1: The most effective conservative management strategies for patients with LBP remains unknown. Manual therapy is routinely used in clinical practice and recommended in Clinical Practice Guidelines, including OMT and DN. It is unknown if a pragmatically applied OMT combined with DN produces larger treatment effects than a pragmatically applied SMT alone for patients with LBP.
Problem 2: Patient factors such as psychological and psychosocial factors, patient recovery expectations, and patient treatment preferences have all demonstrated the ability to influence clinical outcomes in patients with LBP. Currently it is not understood how the presence of multiple patient variables combine to interact with patient outcomes.
Purpose Statement The purpose of this randomized clinical trial is to determine the clinical effectiveness of OMT or DN alone compared with OMT and DN on pain and disability for patients with LBP. Both within and between group effects will be presented. Our hypothesis is that individuals treated with both OMT and DN will experience greater changes in pain and disability compared with those who receive either treatment individually. We also anticipate the presence of patient factors known to influence pain will negatively correlate with patient outcomes and certain combinations of these patient factors may have a stronger influence on clinical outcomes.
Statement of Research Objectives
Specific Aim 1: Determine the comparative effectiveness of pragmatically applied OMT with DN compared to OMT or DN alone for patients with LBP and disability.
Specific Aim 2: Determine the relationship between patient factors and clinical outcomes for individuals with LBP who receive DN and/or OMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The outcome assessor needing access to REDcap will be blinded the treatment group. The clinician providing treatment will be blinded to outcomes.
| Arm | Type | Receives |
|---|---|---|
| Orthopedic Manual Therapy | Active comparator | Other: Orthopedic Manaual Therapy, Other: Home exercise program, Other: Patient educationParticipants randomized to this arm will receive clinician-selected orthopedic manual therapy targeting the joints of the low back. Selected techniques can involve joint mobilizations or spinal manipulation. The dosage parameters will be determined by the clinician. Patient Education Patients will receive education regarding their low back pain, advice to stay active, proper performance of their home exercise program. Home exercise program The program will consist of 10 exercises which the clinician will select 5 they feel would be most beneficial to the patient. These can include aerobic, general strengthening, directional preference, or neural self-mobilizations. |
| Dry Needling | Active comparator | Other: Dry Needling, Other: Home exercise program, Other: Patient educationParticipants randomized to this arm will receive dry needling to the low back and lower extremity while being applied based on clinician-selected areas of symptomatic soft tissue. The dosage parameters will be determined by the clinician. Patient Education Patients will receive education regarding their low back pain, advice to stay active, proper performance of their home exercise program. Home exercise program The program will consist of 10 exercises which the clinician will select 5 they feel would be most beneficial to the patient. These can include aerobic, general strengthening, directional preference, or neural self-mobilizations. |
| Orthopedic Manual Therapy and Dry needling | Experimental | Other: Orthopedic Manaual Therapy, Other: Dry Needling, Other: Home exercise program, Other: Patient educationParticipants randomized to this arm will receive dry needling to the lumbar spine and lower extremity based on clinician-selected areas of symptomatic soft-tissue and or orthopedic manual therapy targeting the joints of the low back. Patient Education Patients will receive education regarding their low back pain, advice to stay active, proper performance of their home exercise program. Home exercise program The program will consist of 10 exercises which the clinician will select 5 they feel would be most beneficial to the patient. These can include aerobic, general strengthening, directional preference, or neural self-mobilizations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are 18 years of age or older, present with LBP and a pain score of > or = 3/10
Key exclusion criteria (1 listed)
- Patients will be excluded if they present with a contraindication to either treatment (malignancy, fracture, myelopathy, osteoporosis, etc.), have a prior surgical history involving the lumbar spine, present with spinal nerve root compression (2 or more neurological findings that includes myotome weakness, dermatomal sensory loss, and/or deep tendon reflexive changes), are seeking litigation, or are receiving other forms of conservative care.
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 |
|---|---|---|
| Orthopedic Manaual TherapyCan include either spinal mobilizations or spinal manipulation therapy targeting the stiff or symptomatic level of the lumbar spine. Various types of mobilization or manipulation may be used based on the therapists clinical reasoning. The therapist will determine which technique and dosage parameters for each subject based on individual patient clinical data. Common mobilizations techniques involve gently and repeatedly applying pressure over different parts of the patient's spine that is associated with their symptoms. For a manipulation, the patient will be positioned in side-lying position. The therapist will then position the patient further to target the symptomatic level. The patient is asked to take a deep breathe in and out. The therapist will slowly add pressure through the trunk and apply a fast but small thrust motion toward the table. | Other | Orthopedic Manual Therapy, Orthopedic Manual Therapy and Dry needling |
| Dry Needlingdry needling both sides of the symptomatic level(s) of the lumbar spine as well as needling other areas in the lower extremity and pelvis based on the results of their clinical evaluation and/or the subjects presenting symptoms. Dry needling involves the insertion of a monofilament needle (nothing is injected) into symptomatic soft tissue. The therapist will determine which technique and dosage parameters for each subject based on individual patient clinical data. | Other | Dry Needling, Orthopedic Manual Therapy and Dry needling |
| Home exercise program5 exercises will be selected from 10 options intended to reinforce the improvements made from treatment. | Other | Dry Needling, Orthopedic Manual Therapy, Orthopedic Manual Therapy and Dry needling |
| Patient educationPatient education on the low back condition, advice to stay active, and home exercise performance. | Other | Dry Needling, Orthopedic Manual Therapy, Orthopedic Manual Therapy and Dry needling |
Primary outcome
PROMIS-29.2
Time frame: Baseline, 1 week, 1 month, and 6 months
Questionnaire that assesses 7 domains with 4 questions with an additional pain intensity numeric rating scale (NPRS). The PROMIS measures have been tested and validated in large reference populations making them suitable for research on different conditions.
3 secondary outcomes
Global Rating of Change
Time frame: 1 week, 1 month, and 6 months
Global Rating of Change for Medication Intake
Time frame: 1 week, 1 month, and 6 months
Health Care Utilization
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 30867144Rubinstein SM, de Zoete A, van Middelkoop M, Assendelft WJJ, de Boer MR, van Tulder MW. Benefits and harms of spinal manipulative therapy for the treatment of chronic low back pain: systematic review and meta-analysis of randomised controlled trials. BMJ. 2019 Mar 13;364:l689. doi: 10.1136/bmj.l689.
- Background: PubMed 29952980Hu HT, Gao H, Ma RJ, Zhao XF, Tian HF, Li L. Is dry needling effective for low back pain?: A systematic review and PRISMA-compliant meta-analysis. Medicine (Baltimore). 2018 Jun;97(26):e11225. doi: 10.1097/MD.0000000000011225.
- Background: PubMed 33064878Corp N, Mansell G, Stynes S, Wynne-Jones G, Morso L, Hill JC, van der Windt DA. Evidence-based treatment recommendations for neck and low back pain across Europe: A systematic review of guidelines. Eur J Pain. 2021 Feb;25(2):275-295. doi: 10.1002/ejp.1679. Epub 2020 Nov 12.
- Background: PubMed 31666220Owen PJ, Miller CT, Mundell NL, Verswijveren SJJM, Tagliaferri SD, Brisby H, Bowe SJ, Belavy DL. Which specific modes of exercise training are most effective for treating low back pain? Network meta-analysis. Br J Sports Med. 2020 Nov;54(21):1279-1287. doi: 10.1136/bjsports-2019-100886. Epub 2019 Oct 30.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Orthopedic Manaual Therapy, Dry Needling and Home exercise program in people with Low Back Pain, Mechanical, run by Youngstown State University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David W Griswold, PhD (330-941-2419, dwgriswold@ysu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS-29.2 (time frame: Baseline, 1 week, 1 month, and 6 months). 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 NCT06150625, 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 29 Nov 2023.