Comparing Dry Needling to Manual Therapy for Patients With Mechanical Low Back Pain
Randomized Controlled Trial Comparing the Use of Dry Needling to Manual Therapy for Patients With Mechanical Low Back Pain.
調査の概要
詳細な説明
Procedures:
Subjects will sign the informed consent prior to any examination procedures. Eligibility assessment will be performed by the treating physical therapist and will include the subject filling out the demographic / health history questionnaire, outcome measures, and a clinical examination. The treating physical therapist will use 2 components of the examination for eligibility criteria into the study. The treating therapist will press on the subject's joints in their back to try to elicit their chief complaint. The treating physical therapist will also press on the soft tissue of the subject's back to check for any symptomatic points. A symptomatic point would include recreation of their chief complaint, tenderness, hypersensitivity, or referred pain. The treating physical therapist will then draw an X on the patient's back where the most symptomatic tissue exists. This point will be used by the data collecting physical therapist in order to collect pain pressure threshold of the area.
The data collecting physical therapist will have the subject complete an Oswestry Disability Index(ODI), gather a measure of the pain from the patient ,and the pain pressure threshold. Each subject will then be allocated to either the manual therapy group or the dry needling group.
Once a subject is assigned to a group, they will receive either dry needling or manual therapy mobilizations by the treating therapist. Each subject will remain in the assigned group as long as they are continuing in the study up to 3 weeks. In addition to the treatments under investigation, a standardized home exercise program will be assigned to each of the subjects by the treating physical therapist. This program will be given to and reviewed with each subject to ensure they understand the exercises and will perform the exercise program 1x/day for the duration they are under the care of the physical therapist for the study. Subjects will be treated on day 1 of their plan of care and subsequent treatments will occur 2x/week for a total of 3 weeks, unless discharge occurs earlier than the 3 week data point. Early discharge will occur if the subject achieves resolution of symptoms or if they decide they no longer wish to be a research participant.
Subsequent sessions will involve the collection of outcome data by the data-collecting therapist followed by treatment performed by the treating physical therapist. No adjustments will be made to the treatment protocol in any of the sessions. Subjects will only be scheduled with and treated by the same treating physical therapist each session. In the event that a treating physical therapist is unable to see a subject participating in the study, the subject will be rescheduled for a different time to receive care.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Ohio
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Youngstown、Ohio、アメリカ、44406
- Youngstown State University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- There will be 72 subjects participating in this study that present with mechanical low back pain, ranging from 18-70 years old. The 72 subjects includes a 20% attrition rate 12 additional subjects. The total needed for analysis is 60 subjects, 30 per group.
Exclusion Criteria:
- Subjects will be excluded if the examining therapist cannot provoke either active or latent MTrPs of the subject's low back muscles and/or elicit symptoms with manual passive movement of the spine at the joints of the low back. Exclusion criteria will also consist of the presence of any red flags revealed in the patient history (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, prior lumbar surgery, current pregnancy, etc.) or examination (i.e. signs consistent with significant nerve root compression). Subjects will be excluded if they demonstrate signs of Chronic Regional Pain Syndrome (CRPS), are currently seeking litigation, are unable to speak English, and/or have been diagnosed with a condition that can cause prolonged MTrPs such as fibromyalgia, hypothyroidism, or iron deficiency. In addition, no patients who have a transmittable blood disease will be included.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Dry Needling
A total of 30 subjects will be randomized to this experimental arm.
If randomized to this arm, subjects will receive dry needling, patient education, and a home exercise program.
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Dry needling involves inserting a dry, mono-filament needle through the skin and into an area of symptomatic soft tissue.
The two-inch needles will be placed segmentally and into the lower extremities following peripheral nerve patterning by the treating physical therapist.
Following initial penetration into the skin over the tender area, the therapist carefully advances the needle into the tissue below the skin.
After the needle has reached the desired depth, the therapist will insert the subsequent needles.
Needles will be placed along the segmental levels of the lumbar spine above and below the tender area identified and into the lower extremity in areas that correlate with a peripheral nerve map.
Needles will remain in the tissue for up to 5 minutes, removed, and appropriately disposed of.
A home exercise program will be given to each subject to be completed in the clinic and at home 1x/day.
The exercises will consist of active range of motion exercises and core stabilization exercises.
The program is standardized for all subjects.
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実験的：Manual Therapy
A total of 30 subjects will be randomized to this experimental arm.
If randomized to this arm, subjects will receive manual therapy, patient education, and a home exercise program.
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A home exercise program will be given to each subject to be completed in the clinic and at home 1x/day.
The exercises will consist of active range of motion exercises and core stabilization exercises.
The program is standardized for all subjects.
The therapist will locate the involved segment using passive accessory intervertebral movements.
The segment will be localized to the level, which provokes the patient's symptoms most easily, and this segment will be determined to be the involved level.
Once this level has been identified, the therapist will compare central glides over the spinous process or a unilateral glide over the facet joint to determine which is more provocative.
Whichever is most provocative will be the location of the treatment.
The therapist will provide 3 bouts lasting 45 seconds just easing into the patient's symptoms at the most provocative level with approximately 45 seconds rest between each bout.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Oswestry Disability Index (change over time)
時間枠：The ODI will be recorded at baseline, 1 week, 2 weeks, and discharge/3 weeks.
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The ODI is a ten question self report measure that assesses the impact of the patient's pain on their ability to perform everyday activities and is currently considered the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain.
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The ODI will be recorded at baseline, 1 week, 2 weeks, and discharge/3 weeks.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Numerical Pain Rating Scale (change over time)
時間枠：The NPRS will be recorded at baseline, immediately following treatment, at 1 week, 2 weeks, and discharge/3 weeks.
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The patient is asked to rate their level of pain on an 11-point numerical scale 0-10 with 0 being "no pain" and 10 being the "worst possible pain."
Pain will be recorded one additional time after the initial treatment session.
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The NPRS will be recorded at baseline, immediately following treatment, at 1 week, 2 weeks, and discharge/3 weeks.
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Pain pressure threshold (change over time)
時間枠：The NPRS will be recorded at baseline, immediately following treatment, at 1 week, 2 weeks, and discharge/3 weeks.
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PPT will be measured as described above using an algometer to the identified MTrPs.
An algometer is an instrument that detects sensitivity to pressure.
The force gauge algometer is placed on the area of a patient's identified MTrP.
Pressure is gradually increased until the person perceives a noxious sensation.
The amount of pressure at the point of pain is recorded then repeated and and PPT will be performed twice each time, and the measures will be averaged together for data analysis.
PPT will be collected one additional time post treatment session 1.
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The NPRS will be recorded at baseline, immediately following treatment, at 1 week, 2 weeks, and discharge/3 weeks.
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Percentage of recovery (one time assessment at the end of the 3 weeks)
時間枠：3 weeks or Discharge
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A global percentage of improvement is a measure of the patient's perception of the change in their condition.
It will be recorded at discharge by asking the subject what percent better they believe their low back problem is compared to when they entered the study.
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3 weeks or Discharge
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Patient Specific Functional Scale Score
時間枠：PSFS score collected at baseline, 1 week, 2 weeks, and 3 weeks or discharge
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The PSFS is a patient identified self-report questionnaire that measures general activity limitations.
The scale ranges from 0 (unable to perform) to 10 (able to perform the activity at the level prior to injury).
The patient reports 3 activities and rates each activity from 0 to 10, which are averaged for a composite score.
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PSFS score collected at baseline, 1 week, 2 weeks, and 3 weeks or discharge
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協力者と研究者
捜査官
- 主任研究者：Ken Learman, PhD、Faculty
- 主任研究者：David W Griswold, Doctorate、Faculty
出版物と役立つリンク
一般刊行物
- Ziaeifar M, Arab AM, Karimi N, Nourbakhsh MR. The effect of dry needling on pain, pressure pain threshold and disability in patients with a myofascial trigger point in the upper trapezius muscle. J Bodyw Mov Ther. 2014 Apr;18(2):298-305. doi: 10.1016/j.jbmt.2013.11.004. Epub 2013 Nov 9.
- Furlan AD, van Tulder M, Cherkin D, Tsukayama H, Lao L, Koes B, Berman B. Acupuncture and dry-needling for low back pain: an updated systematic review within the framework of the cochrane collaboration. Spine (Phila Pa 1976). 2005 Apr 15;30(8):944-63. doi: 10.1097/01.brs.0000158941.21571.01.
- Cook C, Learman K, Showalter C, Kabbaz V, O'Halloran B. Early use of thrust manipulation versus non-thrust manipulation: a randomized clinical trial. Man Ther. 2013 Jun;18(3):191-8. doi: 10.1016/j.math.2012.08.005. Epub 2012 Oct 2.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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