A Clinical Trial Comparing Five Over-The-Counter Non-pharmacological Topical Analgesics for Myofascial Pain: single session findings

ISRCTN	ISRCTN54672559
DOI	https://doi.org/10.1186/ISRCTN54672559
Protocol serial number	N/A
Sponsor	Individual Sponsor (Canada)
Funder	None

Submission date: 24/10/2010
Registration date: 09/11/2010
Last edited: 04/10/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Daniel Avrahami
Scientific

204 Parkmount
Toronto
M4J 4V6
Canada

Study information

Primary study design	Interventional
Study design	Single session randomised placebo controlled double blinded clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A Randomized, Placebo-Controlled Double-Blinded Comparative Clinical Trial of Five Over-The-Counter Non-pharmacological Topical Analgesics for Myofascial Pain: single session findings
Study objectives	This study is designed to assess the hypothesis that the five Over-The-Counter (OTC) Non-pharmacological Topical Analgesics for Myofascial Pain will perform better than the placebo cream with respect to lateral flexion range of motion and pain threshold outcome measures. The literature on myofascial trigger points and non-pharmacologic topical agents is sparse with no randomized clinical trials found to date. A randomized, placebo-blinded clinical trial of non-pharmacological topical analgesics was conducted comparing leading national and professional brands in the treatment of a myofascial trigger point (MTP). Please note that as of 30/11/10 this trial has not received ethics approval. Ethics approval was not obtained from the Canadian Memorial Chiropractic College Research Ethics Board in June 2009 as was stated at the time of registration. The study was performed within a private practice therapy clinic.
Ethics approval(s)	Added 30/11/10: None
Health condition(s) or problem(s) studied	Myofascial Pain/Myofascial Trigger Points
Intervention	Six topical products were tested: three were ointments, two were roll-on gels and one placebo cream which served as the control. 1. Professional Therapy Muscle Care Roll-on (PTMC roll-on) 2. Professional Therapy Muscle Care Ointment (PTMC ointment) 3. Bengay Ultra Strength Muscle Pain ointment (BG) 4. Icy Hot Extra Strength Cream (IH) 5. Biofreeze roll-on gel (BF) 6. Non-medicinal placebo cream (PLA) All of these products were placed in identical 0.5 ounce white plastic screw top containers or 3 ounce. generic white roll-on bottles. Only a coded letter was applied as a label. The master code for these products was kept with the clinic administrator and was unknown to all study participants. Procedures Subjects were seated erect in a comfortable ergonomic chair in a private room. Assessor #1 entered the room and palpated the subjects right shoulder in order to determine the presence and location of a MTP in the upper trapezius muscle adjacent to the 7th cervical vertebrae and the 1st thoracic vertebrae. This was marked with a black dot. Assessor #1 exited the room and assessor #2 entered and performed the original testing of the outcome measures. The rangiometer was placed on the subjects head. From a neutral position, right and left active end-range lateral flexion measurements were recorded. The pressure algometer was applied over the marked trapezius trigger point for the baseline pressure reading. The subject was instructed to indicate when the pressure point was painful. Following the initial outcome measurements, assessor #1 applied one of the six samples, randomized, in the area of the marked pressure point. The subject was instructed to stay seated in the chair with little head movement for five to seven minutes. Following the application of the topical analgesic, assessor #2 reassessed and recorded the pain and range of motion outcome measures. The study was conducted over a 7-day period.
Intervention type	Other
Primary outcome measure(s)	1. Pain at a MTP in the upper trapezius, measured using a pressure algometer and was reported in kg/cm2. 2. Cervical spine lateral flexion, measured using a cervical rangiometer and was reported in degrees. Both measures were assessed pre- and post-intervention and have proven reliable and valid in the assessment of MTPs.
Key secondary outcome measure(s)	Patient satisfaction: Following the intervention, subjects were asked to rate their level of satisfaction on a verbal satisfaction scale (P = poor, F = fair, G = good, E = excellent).
Completion date	30/07/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. Male or female, aged 16-82 2. Subjects were selected from consecutive clinical presentations of patients for treatment in a multidisciplinary health clinic 3. Fifty-six percent of patients presented with shoulder or neck pain 4. Subjects were informed of the nature of the experiment and consented to participate
Key exclusion criteria	1. Acute pain presentation preventing comfortable participation 2. Absence of a palpable tender spot in the right upper trapezius region
Date of first enrolment	01/07/2009
Date of final enrolment	30/07/2009

Locations

Countries of recruitment

Canada

Study participating centre

204 Parkmount

Toronto
M4J 4V6
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes