Pragmatically Applied Orthopedic Manual Therapy and Dry Needling for Low Back Pain.

Youngstown State University

Status: Not yet enrolling

Conditions: Low Back Pain, Mechanical

Treatments: Other: Dry Needling; Other: Orthopedic Manaual Therapy; Other: Patient education; Other: Home exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT06150625

2024-35

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are 18 years of age or older, present with LBP and a pain score of > or = 3/10

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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188 participants in 3 patient groups

Orthopedic Manual Therapy

Active Comparator group

Description:

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.

Treatment:

Other: Patient education

Other: Home exercise program

Other: Orthopedic Manaual Therapy

Dry Needling

Active Comparator group

Description:

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.

Treatment:

Other: Patient education

Other: Home exercise program

Other: Dry Needling

Orthopedic Manual Therapy and Dry needling

Experimental group

Description:

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.

Treatment:

Other: Patient education

Other: Home exercise program

Other: Dry Needling

Other: Orthopedic Manaual Therapy