The Effect of Noxipoint Therapy Versus Physical Therapy With TENS on Chronic Neck Pain
Condition: Cervical Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Chronic cervical pain is a common problem in rehabilitation clinic, but the treatment is time
      consuming and the effect unsatisfactory. Noxipoint® Therapy, developed by Dr. Charles C. Koo,
      is a unique electrical stimulation precisely on corresponding "Noxipoints®" of each injured
      soft tissue, with specific duration and intensity of TENS that induce C-fiber nerve ending
      sensation. Each application typically last for 2 to 5 minutes. Based on observations of the
      clinical application, Noxipoint® Therapy appears to relieve chronic neck and shoulder pain
      significantly with lasting effect, and effectively improves the range of motion. However,
      large-scale double-blinded, randomized control study on the therapy is not available yet.

      The purpose of this study is to compare the effect of Noxipoint® Therapy and physical therapy
      (including the current TENS application) on patients with chronic neck pain. This study is a
      prospective stratified randomized control trial. Eighty subjects with chronic cervical pain
      will be recruited from the Rehabilitation Department or the Physical Therapy Center of
      National Taiwan University Hospital (NTUH). The qualified subjects will be stratified and
      randomly allocated into two arms, 40 persons in each:

        1. Physical Therapy group (PT)

        2. Noxipoint Therapy group (NT) Subjects in either group will be treated for up to 6
           sessions within 3 weeks, about 1.5 hours per session. The treatment will terminate after
           six sessions or earlier if the patient shows no symptoms.

      Subjects will be evaluated before and after the first treatment session and followed up at
      about 4 weeks, 8 weeks, and 12 weeks after the first treatment.

      Outcome measures are (1) the pain scale in the Brief Pain Index, (2) cervical Range of Motion
      (ROM), (3) Quality of Life (QoL) measured with the Interference of Pain to Life section in
      the Brief Pain Index (BPI) and (4) ultrasound elastogram. Pain scale, ROM and QoL measures
      will be taken before and after the first treatment session, and at 4 weeks, 8 weeks and 12
      weeks after the first session. Elastogram will be taken before the first treatment, and about
      four weeks after the first treatment.

      Statistics: The effects of PT and NT will be compared based on two-sample hypothesis testing
      methods. All the estimated P-values are two tailed.
    

Detailed description: 
      Purpose To compare the effect of Noxipoint™ Therapy and physical therapy on subjects with
      chronic neck pain.

      Background There are many interventions for managing the chronic neck pain. The approaches
      include physical therapy, medication and local corticoid injection, of which physical therapy
      (PT) is the most prevalent treatment. Transcutaneous electrical nerve stimulation (TENS) is
      one of the regular treatments of PT and usually used in chronic neck pain as an adjunct
      therapy. However, the application of TENS, including the location, duration and intensity of
      stimulation, is only loosely defined and largely decided by physical therapists and thus vary
      substantially from one application to another.

      In spite of the long history of TENS uses, the results of existing studies, including
      randomized controlled trials (RCTs), have been inconclusive, with some showing benefits of
      TENS, and others showing none. Moreover, the studies that cite some positive effect of TENS
      over placebo also found that the effect does not last in the long run. The only conclusion
      that could be drawn is that TENS sometimes relieves pain in the short term.

      Noxipoint™ Therapy, a particular combination of precise location, intensity and duration of
      electrical stimulation, invented by Charles Koo, the Co-PI of this protocol, may relieve
      general muscular-skeletal pain and recover the muscle function permanently. Based on
      observations of clinical application of Noxipoint Therapy on the neck and the shoulder pain,
      Noxipoint Therapy showed rapid relief and lasting effect several months after the treatment.
      However, a large-scale randomized control study is not available yet.

      The key point of Noxipoint Therapy is that the location of stimulation is the determining
      factor of the efficacy of the pain treatment. In addition, the intensity, wave pattern and
      duration of stimulation also play important roles. The patient's compliance with the
      instruction to avoid stressing the newly recovered muscle/tissue during the "rest period" is
      also mandatory.

      The purpose of this study is to compare the effect of Noxipoint Therapy and physical therapy
      on patients with chronic neck pain.

      Study design

        1. Prospective, patient- and assessor-blinded, stratified, randomized control trial.
           Stratification factor is the patient-reported primary measure (the pain scale) as
           described below. Patients will be assigned to two tiers before randomization.

        2. Outcome measures: (1) pain scale measured in Brief Pain Index (BPI) from 0 to10 (2)
           cervical Range of Motion (ROM), (3) Quality of Life (QoL) using BPI Interference of
           Function, and (4) ultrasound elastogram. The primary outcome is BPI-at-its-Worst.
           Cervical ROM is used to measure functional restoration, BPI Interference of Functions is
           used to measure the quality of life, and elastogram is used to evaluate the myofascial
           condition.

      Subject enrollment

        1. Subject's inclusion criteria: (1) 20 to 70 years of age, (2) diagnosed as chronic
           cervical pain syndrome (ICD9: 723.1) (3) having no less than 6 months of the pain
           history, (4) the pain level >＝ 5 in BPI and (5) with trigger points.

        2. Subject's exclusion criteria: (1) cervical spondylosis, (2) local corticoid injection
           within last two weeks, (3) signs of psychosomatic illness, (4) unwilling to be
           randomized, (5) pregnant woman.

      3.80 subjects will be recruited from the Rehabilitation Department or the Physical Therapy
      Department of National Taiwan University Hospital (NTUH). After initial evaluation, qualified
      subjects will be stratified and randomized into the following two arms, about 40 subjects in
      either arm:

        1. Physical Therapy group (PT)

        2. Noxipoint Therapy group (NT)

      Methods

        1. Intervention:

             1. Physical therapy arm (PT):

                  -  The TENS device used: FDA K071951

                  -  Patients will be treated with standard physical therapy, including the
                     electrical stimulation. Manual therapy, cold/heat therapy or exercise will be
                     applied at the discretion of the physical therapist for about 60 minutes in
                     each session. Patient education and self-care instructions will be provided.
                     TENS will also be performed in each session for about 30 minutes based on the
                     typical PT guidelines, which will serve both as a part of the standard of care
                     and as a placebo equivalent. It will typically be set at Normal mode and 120
                     Hertz rate.

             2. Noxipoint Therapy arm (NT): Patients will be treated with electrical stimulation
                following Noxipoint Therapy guidelines as highlighted below:

                  -  The TENS device used is the same as in PT. Each is calibrated to allow for
                     maximum range in the specifications.

                  -  The pair of electrode pads is placed at the skin surface locations of the
                     corresponding pair of Noxipoints of the injured muscle/soft tissue, for about
                     2- 5 minutes during each application of the electrical stimulation.

                  -  The electrical stimulation is set to induce the C-fiber response (i.e., dull
                     pain, soreness, or achiness) based on the feedback of the patient during the
                     stimulation.

                  -  If the corresponding pain is not eliminated or at least reduced after a couple
                     of applications on correct Noxipoints, apply an ice pack for about 10-15
                     minutes on site before and during the next Noxipoint stimulation to alleviate
                     excessive inflammation.

                  -  For severe chronic neck pain patients, cervical braces are recommended within
                     the first 2-3 days of each treatment session. The patient has to avoid using
                     the treated tissues/muscles during the "Rest Period": Similar to all other
                     cells, the muscle cell healing or regeneration takes time. Patients are
                     instructed not to use the newly recovered muscle/tissue during the "Rest
                     Period", which is about three days if they are forty or younger, plus about
                     one extra day for every 10 additional years of age. If the patient has
                     extensive injured muscles, take two more days of rest. Ice packs may be used
                     during or soon after the session to prevent Delayed Onset of Muscle Soreness
                     (DOMS) from the TENS stimulation.

                  -  Placebo effect consideration: TENS is included in both arms to obfuscate the
                     process. Using TENS in the PT arm serves both as a sham-therapy-equivalent to
                     what is used in the NT arm to neutralize placebo bias, and as a meaningful
                     therapeutic remedy. The subject is thus blinded. Placebo effect consideration:
                     TENS is included in both arms to obfuscate the process. Using TENS in the PT
                     arm serves both as a sham-therapy-equivalent to what is used in the NT arm to
                     neutralize placebo bias, and as a meaningful therapeutic remedy. The subject
                     is thus blinded.

             3. Subjects in either group will be treated for up to 6 sessions within 3 weeks, about
                1.5 hours per session. The treatment will terminate after six sessions or earlier
                if the patient shows no symptoms. No additional treatments will be provided after 6
                sessions.

        2. Evaluation: Pain scale, ROM and QoL will be measured before and after the first
           treatment and at about 4 weeks and 8 weeks after the first treatment. Pain scale and QoL
           may be measured before each session, and at 12 weeks (by phone) after the first
           treatment. Elastogram will be taken before the first treatment and 4 weeks after the
           first treatment. See attached Time Table at the end.

        3. Statistics: The effects of PT and NT will be compared based on two-sample hypothesis
           testing methods. The significant level is set at 0.05. All the estimated P-values are
           two tailed. Missing data will be treated using Last Observation Carried Forward (LOCF)
           method.

        4. Safety: Noxipoint Therapy is as safe as any other TENS application, since it is used
           within the general guidelines of TENS.

        5. Patient Data Security Measure: The principle investigators will monitor the data safety
           with measures, such as keeping the study data separately from its medical data. The
           mapping table between the subject's identity and a randomly assigned identity will be
           maintained separately.

        6. Compensation: Each subject will be compensated NT$400 for the time/transportation cost;
           half of which will be for the treatment and the other half for the follow-up. Dropout
           subjects will be paid pro rata.
    

Intervention name(s): Noxipoint Therapy (NT); Physical therapy(PT)
Intervention type(s): Procedure; Procedure
Intervention description(s): • For severe chronic neck pain patients, cervical braces are recommended within the first 2-3 days of each treatment session. The patient has to avoid using the treated tissues/muscles during the "Rest Period": Similar to all other cells, the muscle cell healing or regeneration takes time. Patients are instructed not to use the newly recovered muscle/tissue during the "Rest Period", which is about three days if they are forty or younger, plus about one extra day for every 10 additional years of age. If the patient has extensive injured muscles, take two more days of rest. Ice packs may be used during or soon after the session to prevent Delayed Onset of Muscle Soreness (DOMS) from the TENS stimulation.; •Placebo effect consideration: TENS is included in both arms to obfuscate the process. Using TENS in the PT arm serves both as a sham-therapy-equivalent to what is used in the NT arm to neutralize placebo bias, and as a meaningful therapeutic remedy. The subject is thus blinded. Placebo effect consideration: TENS is included in both arms to obfuscate the process. Using TENS in the PT arm serves both as a sham-therapy-equivalent to what is used in the NT arm to neutralize placebo bias, and as a meaningful therapeutic remedy. The subject is thus blinded.
Other intervention name(s): Charles Koo's Pain Cure Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: noxipoint; physical therapy; cervical pain; trigger point; neck pain; TENS; transcutaneous electrical nerve stimulation