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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intramuscular Dry-Needling | Experimental | (IMDN) is a minimally invasive procedure where a solid filament needle is inserted into a myofascial trigger point. |
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| Sham Intramuscular Dry-Needling | Sham Comparator | ). Park sham acupuncture needles (AcuPrime) will be used to perform sham needling for this group. The sham needle functions by allowing the blunted needle to cause a pricking sensation when pushed against the skin, but does not penetrate. This will allow the patient to perceive that the needle is entering the skin while also maintaining therapist-patient contact and interaction time |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intramuscular Dry-Needling | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index | self reported questionnaire that is used to measure a patient's permanent functional disability. | Baseline, week 1, week 2 and week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Fear-Avoidance Beliefs Questionnaire | self reported questionnaire that is used to measure a patient's fear associated with movement and/or work | Baseline, week 1, week 2 and week 3 |
| 11 point Numeric Pain-Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominic J Severino, PT,DPT | Contact | 5097774687 | dseverino@whitworth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dominic Severino, PT,DPT | Whitworth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Whitworth University | Recruiting | Spokane | Washington | 99251 | United States |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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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.
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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.
self reported scale that is used to rate subjective intensity of back and leg pain
| Baseline, week 1, week 2 and week 3 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |