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Short-term study on risk-benefit outcomes of two spinal manipulative therapies in the treatment of acute radiculopathy caused by lumbar disc herniation: study protocol for a randomized controlled trial.

Han L, Zhao P, Guo W, Wei J, Wang F, Fan Y, Li Y, Min Y - Trials (2015)

Bottom Line: The pain pressure threshold (PPT) will be measured paraspinally on the tender spot beside the involved joint before and immediately after each SM treatment.Relative risk (RR) of AUR, number needed to harm (NNH) and the 95% confidence intervals of each group will be calculated and compared.Benefit outcomes will be assessed by analyzing the following data recordings: the Numerical Rating Scale (NRS), Oswestry Disability Index (ODI), and Global Perceived Effect (GPE) before enrollment and at the 7th, and 15th day after the treatment.

View Article: PubMed Central - PubMed

Affiliation: PLA Spine Center of TCM Manipulative Orthopedics, Air Force General Hospital of PLA, No. 30, Fu Cheng Street, Hai Dian District, Beijing, 100142, China. sfjhanlei@163.com.

ABSTRACT

Background: That patients with acute radiculopathy caused by lumbar disc herniation (LDH) will benefit from spinal manipulation (SM) treatment has been taken for granted, despite no solid evidence to support that claim. There is a demand for a win-win SM treatment that is both effective and less risky, and we attempt to use this trial to demonstrate such a treatment. In this study, Feng's Spinal Manipulative Therapy (FSM) is selected as the observational SM. FSM can be performed with either manipulation or mobilization, and also can be easily mimicked as a sham SM.

Methods/design: Two hundred and sixteen qualified hospitalized participants will be randomly allocated to one of the three following groups: sham SM, mobilization, or manipulation, according to a ratio of 1:1:1. Participants in each group will receive specific FSM treatments four times, along with basic therapies over a course of 2 weeks. Two days after each SM appointment, risk outcomes will be assessed using a questionnaire developed to identify accompanying unpleasant reactions (AUR). The pain pressure threshold (PPT) will be measured paraspinally on the tender spot beside the involved joint before and immediately after each SM treatment. Relative risk (RR) of AUR, number needed to harm (NNH) and the 95% confidence intervals of each group will be calculated and compared. Benefit outcomes will be assessed by analyzing the following data recordings: the Numerical Rating Scale (NRS), Oswestry Disability Index (ODI), and Global Perceived Effect (GPE) before enrollment and at the 7th, and 15th day after the treatment. Analyses will include comparisons of NRS, ODI and changes at the different visit times among the three groups by Repeated Measures Data ANOVA, an evaluation of reduced scores of NRS and ODI after the therapy to determine if they meet the minimum acceptable outcome (MAO), and the determination of the minimal clinically important difference (MCID) by the average improvement in NRS and ODI scores of all participants who have been allocated to the category 'improved' on the GPE assessment.

Trial registration: This trial is registered in Chinese Clinical Trial Register (ChiCTR) on 19 August 2013 ( ChiCTR-TRC-13003496 ).

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Related in: MedlinePlus

Chart of Feng’s Spinal Manipulative Therapy (FSM). See the difference among the spinal manipulation (SMA), spinal mobilization (SMO) and sham spinal manipulation (SSM).
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Fig1: Chart of Feng’s Spinal Manipulative Therapy (FSM). See the difference among the spinal manipulation (SMA), spinal mobilization (SMO) and sham spinal manipulation (SSM).

Mentions: In this study, Feng’s Spinal Manipulative Therapy (FSM) [23] is selected as the observational SM to be studied, which is a very popular Chinese SM and created by Dr. Tian-you Feng in the 1970s. The FSM technique is performed while the patient is in a sitting position, and the involved segment is precisely pressed by a gentle but stabilized torsion force. Based on FSM treatment, Dr. Feng created ‘the PLA Spine Center of Manipulative Orthopedics’ in the 1980s, and now the center is very famous for Spinal Manipulative Therapy and attracts thousands of patients from throughout China and abroad, which gave us the opportunity to design this trial.. The lumbar concept of the FSM technique is basically similar to any type of traditional spinal manipulation with a focus on loading a torsion force at the involved joints, except more gently and delicately, usually without the signature cracking sound. Only two rotation movements to each side and within the range of motion (ROM) of the lumbar spine were applied during a single treatment (see Figure 1).Figure 1


Short-term study on risk-benefit outcomes of two spinal manipulative therapies in the treatment of acute radiculopathy caused by lumbar disc herniation: study protocol for a randomized controlled trial.

Han L, Zhao P, Guo W, Wei J, Wang F, Fan Y, Li Y, Min Y - Trials (2015)

Chart of Feng’s Spinal Manipulative Therapy (FSM). See the difference among the spinal manipulation (SMA), spinal mobilization (SMO) and sham spinal manipulation (SSM).
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4380109&req=5

Fig1: Chart of Feng’s Spinal Manipulative Therapy (FSM). See the difference among the spinal manipulation (SMA), spinal mobilization (SMO) and sham spinal manipulation (SSM).
Mentions: In this study, Feng’s Spinal Manipulative Therapy (FSM) [23] is selected as the observational SM to be studied, which is a very popular Chinese SM and created by Dr. Tian-you Feng in the 1970s. The FSM technique is performed while the patient is in a sitting position, and the involved segment is precisely pressed by a gentle but stabilized torsion force. Based on FSM treatment, Dr. Feng created ‘the PLA Spine Center of Manipulative Orthopedics’ in the 1980s, and now the center is very famous for Spinal Manipulative Therapy and attracts thousands of patients from throughout China and abroad, which gave us the opportunity to design this trial.. The lumbar concept of the FSM technique is basically similar to any type of traditional spinal manipulation with a focus on loading a torsion force at the involved joints, except more gently and delicately, usually without the signature cracking sound. Only two rotation movements to each side and within the range of motion (ROM) of the lumbar spine were applied during a single treatment (see Figure 1).Figure 1

Bottom Line: The pain pressure threshold (PPT) will be measured paraspinally on the tender spot beside the involved joint before and immediately after each SM treatment.Relative risk (RR) of AUR, number needed to harm (NNH) and the 95% confidence intervals of each group will be calculated and compared.Benefit outcomes will be assessed by analyzing the following data recordings: the Numerical Rating Scale (NRS), Oswestry Disability Index (ODI), and Global Perceived Effect (GPE) before enrollment and at the 7th, and 15th day after the treatment.

View Article: PubMed Central - PubMed

Affiliation: PLA Spine Center of TCM Manipulative Orthopedics, Air Force General Hospital of PLA, No. 30, Fu Cheng Street, Hai Dian District, Beijing, 100142, China. sfjhanlei@163.com.

ABSTRACT

Background: That patients with acute radiculopathy caused by lumbar disc herniation (LDH) will benefit from spinal manipulation (SM) treatment has been taken for granted, despite no solid evidence to support that claim. There is a demand for a win-win SM treatment that is both effective and less risky, and we attempt to use this trial to demonstrate such a treatment. In this study, Feng's Spinal Manipulative Therapy (FSM) is selected as the observational SM. FSM can be performed with either manipulation or mobilization, and also can be easily mimicked as a sham SM.

Methods/design: Two hundred and sixteen qualified hospitalized participants will be randomly allocated to one of the three following groups: sham SM, mobilization, or manipulation, according to a ratio of 1:1:1. Participants in each group will receive specific FSM treatments four times, along with basic therapies over a course of 2 weeks. Two days after each SM appointment, risk outcomes will be assessed using a questionnaire developed to identify accompanying unpleasant reactions (AUR). The pain pressure threshold (PPT) will be measured paraspinally on the tender spot beside the involved joint before and immediately after each SM treatment. Relative risk (RR) of AUR, number needed to harm (NNH) and the 95% confidence intervals of each group will be calculated and compared. Benefit outcomes will be assessed by analyzing the following data recordings: the Numerical Rating Scale (NRS), Oswestry Disability Index (ODI), and Global Perceived Effect (GPE) before enrollment and at the 7th, and 15th day after the treatment. Analyses will include comparisons of NRS, ODI and changes at the different visit times among the three groups by Repeated Measures Data ANOVA, an evaluation of reduced scores of NRS and ODI after the therapy to determine if they meet the minimum acceptable outcome (MAO), and the determination of the minimal clinically important difference (MCID) by the average improvement in NRS and ODI scores of all participants who have been allocated to the category 'improved' on the GPE assessment.

Trial registration: This trial is registered in Chinese Clinical Trial Register (ChiCTR) on 19 August 2013 ( ChiCTR-TRC-13003496 ).

Show MeSH
Related in: MedlinePlus