Efficacy Of Non-Invasive High Power Laser Acupuncture Stimulation In Chronic Non-Specific Low Back Pain

Browse trials for

• Back Pain 2,373
• Low Back Pain 2,818

Keywords

• chronic Low Back pain
• high-intensity laser therapy
• high power laser acupuncture

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 1,941 interventional studies indexed under Back Pain.

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Study arms

• Experimental
  High power laser acupuncture group

  This group will receive high power laser acupuncture (HPLA) +conventional therapy

  Other: high power laser acupuncture (HPLA) · Other: conventional treatment

• Active comparator
  Conventional treatment group

  This group will receive sham laser and The first line of chronic nonspecific low back pain treatment is the conventional treatment.

  Other: conventional treatment · Other: Sham laser

Interventions

• Otherhigh power laser acupuncture (HPLA)

  High power laser therapy A Zimmer Opton pro, integrated High-power class IV laser device (serial N: 15200013306 \& REF: 4682, made in Germany, manufactured by Zimmer Medizin System). It emits radiation in the infrared range to deliver topical heating and raise tissue temperature. The simultaneous application of two wavelengths of laser light (810 and 980nm) provides the user with a huge variety of therapy options. The laser probe - with the small spacer (3.1cm2) , with parameters of 3 watts, 5Hz, 50% duty cycle, 20 joule/ point for 13 seconds with 6.4 j/cm2 . Although a maximum power of 8000 W was reported in two studies, the average power of the lasers used in t

• Otherconventional treatment

  Superficial heat (hot packs). Will be applied 10 - 15 minutes. Guideline-endorsed treatment is to stay active, return to normal activity, and to exercise. Different exercise types are used in the treatment of CLBP such as strength and aerobic training on land as well as specific exercises such as motor control exercises (MCE). General exercises activating the extensor (paraspinals) and flexor (abdominals) muscle groups will be used.

• OtherSham laser

  sham laser (Not active)

Primary outcomes

1. Assessing the change in intensity of pain

   By using visual analoge scale (VAS). It is a valid and reliable measure to assess pain intensity level by patients by making a mark determining a decimal number from 0 to 100 (mm) on line with 'no pain' to the left and severe pain could be to the right. The subjects will rate their perception of pain by making a mark on the VAS line. The distance from the left to the mark will be measured and the accuracy will be adjusted to one decimal place.

   Time frame: at baseline and after 4 weeks of intervention

2. Assessing the change in Back Range of Motion

   By using the Back Range of Motion Instrument (BROM). It is a valid and reliable measure to assess back range of motion (flexion, extension, side bending and rotation) The BROM is uses a patented inclinometer based instrument for measuring lateral side bend in the preferred upright position. The magnetic inclinometer and reference eliminate hip substitution errors. The BROM Basic includes two Universal Inclinometers for measuring flexion and extension of the lumbar spine.

   Time frame: at baseline and after 4 weeks of intervention

3. Assessing the change in Quality of Life

   By using the short version of the WHO Quality of Life Instrument in Arabic. It will be used to assess quality of life. The World Health Organization Quality-of-Life Scale (WHOQOL-BREF) provides a reliable, valid, and brief assessment of quality-of-life. There will be a four-domain score. The four domain scores will denote an individual perception of quality of life in each particular domain. Domains scores are scaled in a positive direction higher score denote higher quality of life. The mean score of items within each domain is used to calculate the domain score. Mean scores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100.

   Time frame: at baseline and after 4 weeks of intervention

4. Assessing the change in endurance of the trunk extensor muscles

   By using Biering-Sorensen test. The Sorensen test allows for a rapid, simple, and reproducible evaluation of the isometric endurance of the trunk extensor muscles. It discriminates between healthy individuals and patients with low back pain and may predict the occurrence of low back pain in the near future. The test consists in measuring the amount of time a person can hold the unsupported upper body in a horizontal prone position with the lower body fixed to the examining table. The Biering-Sørensen test for measuring back muscle fatigue is valid and provides reliable measures of position-holding time and can discriminate between subjects with and without nonspecific low back pain.

   Time frame: at baseline and after 4 weeks of intervention

5. Assessing the change in patient satisfaction

   By using The MedRisk Instrument for Measuring Patient Satisfaction (MRPS). A Self-report measures that sample a variety of items provide clinicians with an array of information that may assist in assessing patient satisfaction. The MRPS questionnaire is valid and reliable for measuring patient satisfaction. It has a 2-factor structure: "internal," relating to the patient-therapist interaction, and "external," describing no therapist issues such as admissions and clinic environment.

   Time frame: at baseline and after 4 weeks of intervention

Individual participant data

Plan to share: Undecided