Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201711002771340 Date of Approval: 15/11/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Laser Acupuncture in the Management of Knee Osteoarthritis
Official scientific title Relative Therapeutic Efficacy of Laser Acupuncture Applied at Different Acupuncture Points in the Symptomatic Management of Knee Osteoarthritis: A Randomised Controlled Trial
Brief summary describing the background and objectives of the trial Knee Osteoarthritis (OA) is the commonest and most important rheumatologic cause of disability and handicap, and an important health care challenge with major resource implications. The study aims to evaluate the relative efficacy of low level laser therapy applied at some selected acupuncture points (knee and ankle-based) in the symptomatic management of knee OA.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Osteoarthritis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 24/11/2014
Actual trial start date 25/11/2014
Anticipated date of last follow up 25/12/2014
Actual Last follow-up date 16/01/2015
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group B (Laser Acupuncture at Distal Points) A class IIIB laser with a wavelength of 830nm and a LED infrared probe; frequency of 20 kHz; intensity or dose of 1.2J. Treatment duration: 1 min/point with a total of 5 minutes; 3 times a week for 3 weeks. On the affected knee, the laser probe was placed sequentially and perpendicularly at the distal acupuncture points (SP6, KI3, BL60 and GB36). Protocol was adopted from Al Rashoud et al 7
Experimental Group Group A (Laser Acupuncture at Basic Points) A class IIIB laser with a wavelength of 830nm and a LED infrared probe and frequency of 20 kHz; intensity or dose of 1.2J. Treatment duration of 1 minute per point with a total of 5 minutes per participant was used, 3 times a week for 3 weeks. (Laser acupuncture at the basic acupuncture points located around the knee joint + intervention in control group). On the affected knee, the laser probe was placed sequentially and perpendicularly at the basic acupuncture points (ST35, ST36, SP9, GB34 and Xi-Yan) (Protocol adopted from Al Rashoud et al.) 7
Control Group Group C (Control Group) 1 set of 10 repetitions with a 6 sec hold and a 10 sec rest between repetitions + cycle for 5 min with a rest period of 10 mins 3 times a week for 3 weeks Isometric quadriceps exercises and cycle ergometer exercise 6 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Knee pain for more than 25 of the past 30 days 2. Morning stiffness of less than 30 minutes. 3. Crepitus in the knee. OR 1. Knee pain for more than 25 of the past 30 days and 2. Osteophytes on x-ray examination of the knee, indicating knee OA38. 3. Patients with knee OA, who had pain for more than 25 of the past 30 days have any of the following criteria, were also recruited: 1. Erythrocyte sedimentation rate <20 mm/1st hour. 2. Obliteration of joint space. 3. Patients with bilateral knee pain 4. Male and female patients. 5. Patients will pain level ¿3 on a visual analogue scale. 1. Patients with low back pain: patients with radicular back pain may complain of knee pain, and thus that would interfere with perception of pain due to OA. 2. Patients on Non-Steroidal Anti Inflammatory Drugs (NSAIDS) and other analgesic; as this would interfere with the result, since patients may experience decreased pain threshold. 3. Tumor in the lower limb as it is relatively contraindicated in laser therapy. This was ruled out at the initial diagnosis stage from the orthopedic department. 4. Patients with solar eczema photosensitivity and sunlight hypersensitivity: Patients with solar eczema or hypersensitivity to sunlight may react to laser therapy when high photon densities are used. 5. Patients who have earlier been exposed to laser therapy at the knee and and/or ankle joint, according to Al Rashoud et al35, laser therapy has a long term (6 month) post intervention effect. 6. Patients with labile epilepsy ¿ A pulsing light (especially with 5-10 Hz frequency) can induce epileptic attacks. 41 Year(s) 71 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 24/11/2014 Hospitals Management Board
Ethics Committee Address
Street address City Postal code Country
Board Headquarters, PMB 3540, Post Office Road, Kano Kano 671101 Nigeria
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 06/11/2014 Bayero University Kano
Ethics Committee Address
Street address City Postal code Country
Gwarzo Road, New Site Kano 671101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Pre and Post intervention (0 and 3 weeks).
Primary Outcome Range of motion Pre and Post intervention (0 and 3 weeks).
Primary Outcome Physical function Pre and Post intervention (0 and 3 weeks).
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala Mohammed Specialist Hospital Mohammed Abdulahi Wase Road, Kano Municipal Kano 671101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Sponsored
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shmaila Hanif Department Of Physiotherapy, Faculty of Allied Health Sciences, Bayero University Kano Kano 671101 Nigeria University
Primary Sponsor Bashir Abdulhakim Musa Department Of Physiotherapy, Faculty of Allied Health Sciences, Bayero University Kano Sokoto 840 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Shmaila Hanif Department Of Physiotherapy Kano 671101 Nigeria
Aishat Shittu Department Of Physiotherapy Kano 671101 Nigeria
Bashir Abdulhakim Musa Usmanu Danfodio University Teaching Hospital, Sokoto Sokoto 840 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bashir Abdulhakim Musa bashirabdulhakim@yahoo.co.uk +2348134093144 Usmanu Danfodio University Teaching Hospital, Sokoto
City Postal code Country Position/Affiliation
Sokoto 840 Nigeria Physiotherapist
Role Name Email Phone Street address
Principal Investigator Shmaila Hanif shelllshelll@yahoo.com +2348038871817 Department Of Physiotherapy, Faculty of Allied Health Sciences, Bayero University Kano
City Postal code Country Position/Affiliation
Kano 671101 Nigeria Assistant Professor
Role Name Email Phone Street address
Principal Investigator Aishat Shittu abdulazeezaisha@gmail.com +2348036785233 Department Of Physiotherapy, Faculty of Allied Health Sciences, Bayero University Kano
City Postal code Country Position/Affiliation
Kano 671101 Nigeria Lecturer I
Role Name Email Phone Street address
Public Enquiries Bashir Abdulhakim Musa bashirabdulhakim@yahoo.co.uk +2348134093144 Usmanu Danfodio University Teaching Hospital, Sokoto
City Postal code Country Position/Affiliation
Sokoto 840 Nigeria Physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Shmaila Hanif shelllshelll@yahoo.com +2348038871817 Department Of Physiotherapy, Faculty of Allied Health Sciences, Bayero University Kano
City Postal code Country Position/Affiliation
Kano 671101 Nigeria Assistant Professor
REPORTING
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