Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Daniel Avrahami


Contact details

204 Parkmount
M4J 4V6

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

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 hypothesis

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

Added 30/11/10: None

Study design

Single session randomised placebo controlled double blinded clinical trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

Not available in web format, please use contact details to request a patient information sheet


Myofascial Pain/Myofascial Trigger Points


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.

Subjects were seated erect in a comfortable ergonomic chair in a private room. Assessor #1 entered the room and palpated the subject’s 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 subject’s 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



Phase IV

Drug names

Primary outcome measures

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 MTP’s.

Secondary outcome measures

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).

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants

120 subjects were entered into the study, 20 in each group (57:63 male:female)

Participant exclusion criteria

1. Acute pain presentation preventing comfortable participation
2. Absence of a palpable tender spot in the right upper trapezius region

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

204 Parkmount
M4J 4V6

Sponsor information


Individual Sponsor (Canada)

Sponsor details

One St Clair Avenue East
Tenth Floor
M4T 2V7

Sponsor type

Hospital/treatment centre



Funder type


Funder name


Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes