Pulse Ultrasound and Kneading Massage in Non- Specific Chronic Low Back Pain
Condition: Non Specific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Back pain is one of humanity most frequent complains. About nine of ten adults experience
      back pain at some points in their life and five out of ten working adults have back pain
      every year. When continued for long period it may constitute a disability which tries the
      patient of the most stoical individual as well as the doctor called to bring relief to the
      suffering victim.

      Kneading massage with topical analgesic is a common practice by physiotherapist especially in
      Nigeria in the management of low back pain, work has been done to know the efficacy of lofnac
      gel (topical analgesic) via phonophoresis in the management of low back pain(ojoawo,2015),
      but the comparison of the efficacy of kneading massage and phonophoresis in the management of
      low back pain has not been well documented. The purpose of this study therefore, is to
      compare the efficacy of kneading massage and phonophoresis using lofnac gel in the treatment
      of non-specific chronic low back pain.
    

Detailed description: 
      The subjects for the study were patients with chronic non-specific low back pain (CNSLBP)
      receiving treatment at Physiotherapy Department, Osun State Specialist Hospital, Oshogbo,
      Nigeria. The inclusion criteria for the patients were patients with non-specific low back
      pain with symptom of pain lasting more than three months. Patients with nerve roots symptoms,
      underlying systemic or visceral disease, and specific conditions such as neoplasms, fracture,
      ankylosing spondylitis, previous low back surgery, and pregnancy were excluded from the
      study. The design of the study was quasi-experimental design.

      Among other screening procedures, spinal movements that provoked pain were noted because
      spinal pain of mechanical origin may be reproduced by movement which induces tension and
      neural sliding 15). Straight leg raising and Ely's test were carried out according to Nwuga
      16) and were found to elicit pain at the lower back. X- ray report of each patient was also
      reviewed and none of the reports indicated osteoporosis, carcinoma, or pot disease.

      In order to determine the number of subjects to be involved, a sample size equation to
      compare two means according to Eng,17) was used:

      N= 4δ2(Zcrit + Zpower)2/D2 Where N is the sample size (the sum of sizes of both comparison
      group). Where δ is the standard deviation of each group (assumed to have a value of six and
      to be equal for both groups). Zcrit is the standard normal deviation corresponding to the
      selective significant criterion [i.e. 0.05 (95% =1.960)].

      4 Zpower is the standard deviation corresponding to the selective statistical power (i.e
      0.80=0.842).

      D is the minimum expected difference between the two mean values, to be significant the value
      should be 2, therefore D = 5 is chosen .

      N=4*62(1.96 + 0.842)2/52 =45.22= 45 Therefore, the total number of 50 subjects were enrolled
      for the study: 25 subjects for the PUS group and 25 subjects for the KM group in order to
      give room for attrition. For the purpose of the study the following instruments were used:
      verbal-rating scale, Roland-Morris disability questionnaire, and an ultrasound machine, among
      others.

      The verbal rating scale (VRS) is a 10-point scale with 1 and 10 indicating the extremes used
      to assess pain. The VRS was validated with the visual analogue scale by Williamson and
      Hoggart 18) who concluded that VRS provides a useful alternative to the visual analogue scale
      scores in the assessment of chronic pain. VRS was used to measure present pain, i.e., pain at
      the time of study.

      Roland Morris Disability Questionnaire (RMDQ): This is a commonly utilised instrument for
      measuring spinal disability as an outcome measure 19). It is a 24-item questionnaire that is
      relevant to low back pain disability. RMDQ is easy to score by totalling the sum of circled
      items (maximum is 24) which represent the final score. The Roland Morris study was referred
      to as the best single study of assessing short-term outcome of primary care patients with low
      back pain20).

      Ultrasound machine (with pulse and continuous mode; Sonopuls 490, Enraf-Nonius B.V.,
      Rotterdam, The Netherlands): This was used to produce the ultrasonic wave for phonophoresis.

      Subjects were randomized into the two groups as follows: Envelopes which contained alphabets
      A and B were made. Subjects were asked to pick from the envelopes. All subjects who picked A
      were assigned to ultrasound (PUS) group, whereas subjects who picked B were assigned to
      kneading massage (KM) group.

      Ethical approval was obtained (HREC No: IPHOAU/12/784) from the Health Research and Ethics
      Committee, Institute of Public Health, Obafemi Awolowo University, Ile-Ife, Nigeria, and
      informed consent of the participant was obtained.

      5 Subjects in each group received 12 sessions of treatment within a period of six weeks of
      treatments. Subjects in each group were placed on stabilization exercise for 20 minutes.
      Pulse ultrasound was administered for the subjects in pulse ultrasound group and kneading
      massage for the control group. Lofnac gel was used as topical gel for the subjects in the two
      groups. Treatment was administered twice (Monday and Fridays of every week for six weeks).
      Assessment was done before the treatment began and every Mondays of the week of the
      treatment.

      The PUS group received pulse mode of ultrasound (sonoplus 490s), with frequency of 1MHZ and
      intensity of 1.5w/cm according to Ebadi et al 10). Grey's formula was used to estimate the
      duration of ultrasound (US) for each patient 21). The average local exposure time was one
      minute and the effective radiating area of the transducer head was 5 cm2. For a patient with
      an area of low back pain of 40 cm2, the required total treatment time was: 1 min × (40 cm2/5
      cm2) = 8 minutes. US was applied using slow circular movements, with the transducer head
      placed over the painful paravertebral low back region and Lofnac gel used as coupling medium.

      Kneading massage was done with the two hands maintaining a slow circular compression of soft
      tissues against underlying bone. Pressure was applied as the hands moved proximally,
      continuously maintaining a contact with the skin, according to Goat22). Lofnac gel was used
      as a coupling medium for the massage. This was done for an approximately ten and 12 minutes.

      For stabilization exercise, a supervised exercise program was employed for each patient. The
      exercises included posterior pelvic tilts, sit-ups, bridging, quadruped exercises, and
      posterior hip and knee muscles stretching 23). Not all patients could do all the exercise at
      a stretch; exercises were done according to the levels of tolerance and endurance of each
      patient. Patients were instructed to perform two to three stretches (of all muscles) per
      treatment and hold the stretch for 20 seconds unless it hurts. Strengthening exercises
      started with five repetitions and progressed according to each patient's improvement, to
      three sets of 10 repetitions 10).

      In order to avoid co-interaction, subjects were informed not to participate in any other
      exercise or treatment program until the end of the follow-up period. Also they were informed
      not to take any analgesic drug during the period of this treatment without the consent of the
      researchers. However, no patients requested for additional medication apart from the
      treatment in the department. The primary measure was pain intensity and the secondary outcome
      measure was disability index. They were measured by a separate physiotherapist who was
      independent 6 of the study every week of the treatment. Data for pre-treatment, third week,
      and six week of treatment were used for data analysis.

      The data was analyzed using Statistical Package for Social Sciences (SPSS 17). Descriptive
      statistics and inferential statistics were used to summarize the data. Independent-t-test was
      used to compare the anthropometric indices of subjects in each group. Repeated measure
      analysis of variance (ANOVA) was used to compare the mean values of pre-treatment, third-week
      and sixth-week pain intensity and physical function within the group and across the group.
      Post hoc analyses were carried out when necessary. An alpha level of <0.05 is set as
      significant level.
    

Intervention name(s): PULSE ULTRASOUND; KNEADING MASSAGE
Intervention type(s): Other; Other
Intervention description(s): For group A, The PUS group received pulse mode of ultrasound (sonoplus 490s), with frequency of 1MHZ and intensity of 1.5w/cm according to Ebadi et al 10). Grey's formula was used to estimate the duration of ultrasound (US) for each patient 21). The average local exposure time was one minute and the effective radiating area of the transducer head was 5 cm2. For a patient with an area of low back pain of 40 cm2, the required total treatment time was: 1 min × (40 cm2/5 cm2) = 8 minutes. US was applied using slow circular movements, with the transducer head placed over the painful paravertebral low back region and Lofnac gel used as coupling medium.; Kneading massage was done with the two hands maintaining a slow circular compression of soft tissues against underlying bone. Pressure was applied as the hands moved proximally, continuously maintaining a contact with the skin, according to Goat22). Lofnac gel was used as a coupling medium for the massage. This was done for an approximately ten and 12 minutes.
Other intervention name(s): ULTRASOUND; MASSAGE
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total number of 50 subjects were enrolled for the study: 25 subjects for the PUS group and 25 subjects for the KM group in order to give room for attrition. For the purpose of the study the following instruments were used: verbal-rating scale, Roland-Morris disability questionnaire, and an ultrasound machine
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ultrasound; kneading-massage; low back pain; pain intensity; disability