Low Back Pain
Conditions
Keywords
Low Back Pain, Dry-Needling, Myofascial Pain, Treatment Based Classification
Brief summary
The purpose of this study is to investigate specific clinical characteristics, amongst those with low back pain, that identify patient appropriateness for Intermuscular Dry-Needling (IMDN) and to develop a prediction tool that can be used by clinicians.
Detailed description
The aim of the CPR is to identify patients with LBP who are likely to benefit from IMDN. Improvement of patient-reported outcomes and clinical measures of pain are the outcomes being predicted by the model. The CPR will be developed in a double-phase design. The first phase will be an RCT, 2 x 3 group (IMDN or Sham) by time (pretest, post-treatment week 1, post-treatment week 2, posttest, follow-up) with repeated measures on timeframe. This design will establish if improvement of patient reported outcomes and clinical measures of pain are achieved because of the IMDN treatment. Furthermore, each group will receive the same type and volume of lumbar and hip stretching exercises in conjunction with their assigned needling regimen. The second phase will utilize logistic regression analysis to identify associations between the groups' demographic, historical, clinical variables and short-term pain and disability outcomes. This type of analysis will be able to identify strong predictors of the treatment outcome. Various processes will be used to determine optimal model fit for analysis.
Interventions
OTHERIntramuscular Dry-Needling
It is a minimally invasive procedure where a solid filament needle is inserted deeply into a myofascial trigger point (MTrP) within a muscle in an attempt to abate it and illicit a desired treatment effect.
Sponsors
Whitworth University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
After the physical examination has been performed, each participant will be randomized to receive IMDN or SIMDN. Randomization will be completed by use of a computer-generated list of random numbers that will designate group assignment. The PI will inform the study PTs of the participants group assignment. The list will be maintained by a research assistant who is not involved with participant recruitment, examination or treatment. Participants will be blinded to group assignment.
Intervention model description
The first phase will be an RCT, 2 x 3 group (IMDN or Sham) by time (pretest, post-treatment week 1, post-treatment week 2, posttest, follow-up) with repeated measures on timeframe. The second phase will utilize logistic regression analysis to identify associations between the groups' demographic, historical, clinical variables and short-term pain and disability outcomes. This type of analysis will be able to identify strong predictors of the treatment outcome. Various processes will be used to determine optimal model fit for analysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and females between the ages of 18 and 60 years with non-traumatic low back pain between the 12th rib and the buttock region. * Participants must also report an Oswestry Disability Index score of at least 20/100 points.
Exclusion criteria
* Participants must be able to speak and read English. * Individuals who are currently pregnant, currently taking pain narcotic medication or have had a prior surgery in the lumbosacral spine * Those participants whose BMI is greater than 35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index | Baseline, week 1, week 2 and week 3 | self reported questionnaire that is used to measure a patient's permanent functional disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fear-Avoidance Beliefs Questionnaire | Baseline, week 1, week 2 and week 3 | self reported questionnaire that is used to measure a patient's fear associated with movement and/or work |
| 11 point Numeric Pain-Rating Scale | Baseline, week 1, week 2 and week 3 | self reported scale that is used to rate subjective intensity of back and leg pain |
Countries
United States
Contacts
Primary ContactDominic J Severino, PT,DPT
Outcome results
None listed