Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202111577053926 Date of Approval: 18/11/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Near Infra-red Light on Chronic Low Back Pain
Official scientific title Effectiveness of Polarized Near Infra-red Light on Myofascial Trigger Points in Chronic Non-Specific Low Back Pain
Brief summary describing the background and objectives of the trial Few studies have been made to investigate the effect of Polarized Near infrared therapy on musculoskeletal disorders and by which proving its significant effect through further more investigations. So, this study was conducted to investigate the effect of Polarized Near infrared therapy (NIR) on myofascial trigger points in patients with Non-specific chronic low back pain. This study also provided new insights into the gap of previous studies on Polarized Near infrared therapy (NIR) in relieving pain and restoring lumbar ROM and function in patients with Non-specific chronic low back pain. According to the inclusion and exclusion criteria, this study was conducted on a sample of (42) participants (male and female) suffering from Chronic Non-specific LBP. Their age ranged from 25-45 years and were randomly assigned into two equal groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/02/2020
Actual trial start date 14/04/2020
Anticipated date of last follow up 11/06/2022
Actual Last follow-up date 10/05/2022
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants) 42
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Polarized Near Infrared light therapy •Experimental group received Polarized Near-IR radiation therapy (NIR) with previously calibrated equipment (Medolight.BIOPTRON, Zepter, Poland). Subjects were instructed to lie in prone lying position. Medolight was placed gently touching the paravertebral lower back zone, trigger points or acupressure points, then was held in place for 10 minutes. It consists of 108 light emitting diodes, (LED), with (wavelength of 880+/- 30 nm , power density of 4mW/cm2 , frequency of 50 HZ and energy density of 1.6 J/cm2 ). •Therapeutic Exercises for 20 minutes. 12 sessions / 4 weeks A block randomization schedule was created using a computer-generated random number table, which was used to allocate patients to one of the two treatment groups. Sealed opaque envelopes were used to ensure allocation concealment. Once the study physiotherapist obtained the informed consent and baseline data, the patient was given a study number, an explanation of the study and a short history and physical examination. All patients were assessed before the treatment and at the end of sessions (total of 12 sessions) along with one week follow up by an assistant physical therapist who was blind to the treatment procedures. Experimental group received polarized near-infrared therapy in addition to LBP conventional therapy. •Polarized Near-IR Radiation Therapy Device: Polarized NIR radiation therapy with previously calibrated equipment (Medolight.BIOPTRON, Zepter, Poland). The device consists of 108 light emitting diodes, (LED), with wavelength of 880+/- 30 nm , power density of 4mW/cm2 , frequency of 50 HZ and energy density of 1.6 J/cm2. •Therapeutic Exercises program started with stretching routines for the lower limbs as well as the lower back. Then, strengthening exercises for abdominal and paravertebral muscles of the low back was gradually added to each session. 21
Control Group Polarized Near infrared light therapy •Sham device ( NIR device turned off ) was placed gently touching the paravertebral lower back zone, trigger points or acupressure points, then was held in place for 10 minutes. •Therapeutic Exercises for 20 minutes. 12 sessions / 4 weeks A block randomization schedule was created using a computer-generated random number table, which was used to allocate patients to one of the two treatment groups. Sealed opaque envelopes were used to ensure allocation concealment. Once the study physiotherapist obtained the informed consent and baseline data, the patient was given a study number, an explanation of the study and a short history and physical examination. All patients were assessed before the treatment and at the end of sessions (total of 12 sessions) along with one week follow up by an assistant physical therapist who was blind to the treatment procedures. Control Group received a Sham Device in addition to LBP conventional treatment. The exercise program started with stretching routines for the lower limbs as well as the lower back. Then, strengthening exercises for abdominal and paravertebral muscles of the low back were gradually added to each session. 21 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects were admitted into the study if they met the following criteria • 25 – 45 years of age. • Body mass index (normal) 18.5 to 25 Kg/cm2 • Chronic non-specific, non-radiation LBP of more than 3 months duration between T12 and the gluteal fold. • Subjects are chosen from both sexes. • All subjects are medically stable and do not suffer from any other diseases or medical problems which may affect the study result. • Conscious and without any cognitive impairment. Subjects were excluded if they exhibited any of the following • Diagnosis of fibromalagia • Self-reported history of malignancy, vertigo and stroke. • Low back surgery with implant. • Suffering from haemophilia, sever diabetes, tumour or function of blood coagulation disorder. • Subjects with serious cardiovascular disease, neurological disease and metabolic disease. • LBP accompanied by specific pathological conditions. • Pregnancy. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 45 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/05/2019 Research Ethical Committee Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
Ahmed El Zayat Ben El Sarayt El Dokki Street Cairo 11865 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Intensity - A block randomization schedule was created using a computer-generated random number table, which was used to allocate patients to one of the two treatment groups, Group A and Group B. Sealed opaque envelopes were used to ensure allocation concealment. Once the study physiotherapist obtained the informed consent and baseline data, the patient was given a study number, an explanation of the study and a short history and physical examination. All patients were assessed before the treatment and at the end of sessions (total of 12 sessions) along with one week follow up by an assistant physical therapist who was blind to the treatment procedures. Pain Intensity is measured by Numeric Pain Rating Scale (NPRS) which is a one-dimensional measure of pain intensity in adults including those with chronic pain. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0–10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Before and after one month. Follow up after one month
Secondary Outcome Pain Pressure Threshold of Quadratus Lumborum and Gluteus Medius (PPT) - A block randomization schedule was created using a computer-generated random number table, which was used to allocate patients to one of the two treatment groups. Sealed opaque envelopes were used to ensure allocation concealment. Once the study physiotherapist obtained the informed consent and baseline data, the patient was given a study number, an explanation of the study and a short history and physical examination. All patients were assessed before the treatment and at the end of sessions (total of 12 sessions) along with one week follow up by an assistant physical therapist who was blind to the treatment procedures. Pressure Algometer A simple hand-held device used to measure pain level by determining pressure pain threshold (PPT) using a pressure transducer probe that is placed on a point. This algometer registers the force (in kilograms per square centimetre) that is recorded is usually the amount of pressure that causes pain, the PPT. Pressure pain threshold (PPT) as mentioned was measured using a pressure algometer with a dial gauge that could be set from 0 to 7.7 kg/cm2 and a rod. The end of the rod was a 1-cm-wide plastic plate; this was placed in direct contact with the marked MTrPs. Vertical pressure was adjusted to these MTrPs at a speed of 1 kg/s until the participant expressed the first sensation of pain. All the participants had MTrPs in the gluteus medius and quadratus lumborum on at least one side that persisted for > 3 months. Before and after one month. Follow up after one month
Secondary Outcome Back Disability Index - A block randomization schedule was created using a computer-generated random number table, which was used to allocate patients to one of the two treatment groups. Sealed opaque envelopes were used to ensure allocation concealment. Once the study physiotherapist obtained the informed consent and baseline data, the patient was given a study number, an explanation of the study and a short history and physical examination. All patients were assessed before the treatment and at the end of sessions (total of 12 sessions) along with one week follow up by an assistant physical therapist who was blind to the treatment procedures. Roland-Morris Low Back Pain And Disability Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale.The RMQ has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain. The Arabic version (which was crucial since the study was conducted in Egypt and all the partients were Egyptians) of the RMDQ has good comprehensibility and acceptability, high internal consistency and reliability, low correlation against pain intensity, and good agreement with the English RMDQ. The patient was instructed to put a mark next to each appropriate statement. Then the total numbers of marked statements were added to get the patient’s score. Before and after one month. Follow up after one month
Secondary Outcome Lumbar Flexion and Rotation ROM - A block randomization schedule was created using a computer-generated random number table, which was used to allocate patients to one of the two treatment groups. Sealed opaque envelopes were used to ensure allocation concealment. Once the study physiotherapist obtained the informed consent and baseline data, the patient was given a study number, an explanation of the study and a short history and physical examination. All patients were assessed before the treatment and at the end of sessions (total of 12 sessions) along with one week follow up by an assistant physical therapist who was blind to the treatment procedures. Modified-modified Schöber's test is a valid and reliable test for measuring the lumbar flexion ROM. The patient was instructed to stand with his back towards the examiner. The examiner located the inferior margin of the SIPS with the thumbs and then marked the intersections of the SIPS by drawing a horizontal line. The second line was drawn 15 cm above the midpoint of the first horizontal line. The difference between the measurements in erect and flexion positions indicates the outcome of the lumbar flexion range of motion. Lumbar Rotation ROM was measured Before and after one month. Follow up after one month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Atris General Hospital Atris village - opposite to Atris Elementry School - Mansheyt Al Qanatir - Giza Giza 12566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tukaram Shiryan 6th October, Zewail Street Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tukaram Shiryan 6th October, Zewail Street Giza Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Aya Ahmed Hadayek October, Beta gardens street Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fatma Ameen fatma_sedek@gmail.com 00201223417697 Ahmed El Zayat Ben El Sarayt El Dokki Street
City Postal code Country Position/Affiliation
Cairo Egypt Professor at the Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Eman Embaby eman_ahmed@cu.edu.eg 00201005220648 Ahmed El Zayat Ben El Sarayt El Dokki Street
City Postal code Country Position/Affiliation
Cairo Egypt Assit.Prof.Doctor at the Faculty Of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Eman Embaby eman_ahmed@cu.edu.eg 00201005220648 Ahmed El Zayat Ben El Sarayt El Dokki Street
City Postal code Country Position/Affiliation
Cairo Egypt Assit.Prof.Doctor at the Faculty Of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after de-identification. Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication. No end date. Anyone who wishes to access the data. For any purpose. Data are available indefinitely.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information