Treatment of Myofascial Trigger Points in common shoulder disorders by physical therapy: a randomised controlled trial

ISRCTN	ISRCTN75722066
DOI	https://doi.org/10.1186/ISRCTN75722066
Secondary identifying numbers	NL16459.091.07

Submission date: 03/07/2007
Registration date: 06/07/2007
Last edited: 25/02/2021

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Mr Carel Bron
Scientific

Paulus Potterstraat 46
Groningen
9718 TK
Netherlands

Phone	+31 (0)50 312 0377
Email	c.bron@home.nl

Study information

Study design	An examiner-blinded randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Treatment of Myofascial Trigger Points in common shoulder disorders by physical therapy: a randomised controlled trial
Study acronym	ToMTriP
Study objectives	The primary aim of this study is to investigate the effectiveness of inactivation of Myofascial Trigger Points (MTrPs) in shoulder muscles by physical therapy on symptoms and functioning of the shoulder in daily activities in a population of chronic a-traumatic shoulder patients when compared to a wait-and-see strategy. In addition, we investigate the recurrence rate during a one-year-follow-up period. In the current study we will test the following hypothesis (H0): A physical therapy treatment to inactivate MTrPs within a three months period is as effective as a wait and see approach of patients with chronic shoulder complaints in a three month period.
Ethics approval(s)	Radboud University Nijmegen Medical Centre (The Netherlands) on 21/05/2007 (ref: CMO 2007/22).
Health condition(s) or problem(s) studied	Musculoskeletal chronic shoulder disorders
Intervention	The initial sample size is based on the assumption that the overall score of the primary outcome measure DASH shows a mean improvement of 15 points [SD = 22]. To test the null hypothesis of equality of treatment at a = 0.05 with 90% power and assuming a uniform dropout rate of 5%, it was calculated that 52 patients in each group would be sufficient. The patients in the intervention group will be treated by a physical therapist once a week for a maximum period of 12 weeks. The treatment starts with inactivation of the active (pain producing) MTrPs by using manual techniques (compression on the trigger point, manual stretching of the trigger point area and the taut band) combined with intermittent cold application by using ice-cubes followed by stretching the muscle according to Travell to further inactivate the MTrPs. Manual pressure will decrease the sensitivity of the painful nodule in the muscle while other massage techniques will mobilise and stretch the contracted muscle fibres. The application of the ice-cubes has a desensitising effect, and makes it easier to stretch shoulder muscles. Each treatment session will end with a heat application to increase the circulation of the involved muscles. Patients will be advised to do stretching exercises and will be taught to perform these correctly by means of surface-electromyography-assisted stretching. Furthermore they will be advised to perform relaxation exercises, and to apply heat (like a hot shower, hot packs) several times (at least twice) a day. If there is abnormal measurable higher electromyographic activity in the upper trapezius muscle (measured by surface Electromyography [sEMG] using a Myomed 932 [Enraf Nonius, Delft, the Netherlands]) during standing and/or sitting, relaxation exercises will be performed using a portable myofeedback device (Myotrac I, Thought Technology, Quebec, Canada). Abnormal sEMG activity is defined as a constantly measured value above 1 - 5% of the maximally voluntary contraction, which is in general above 10 microvolt, during several minutes and the patient is not able to relax the muscle spontaneously or on request. Finally, all patients will receive ergonomic recommendations, and instructions to assume and maintain good posture. Manual high velocity thrust techniques of the cervical spine and the shoulder and dry needling are excluded from the treatment protocol, because not all participating physical therapists are skilled to perform these techniques. The content of each session may vary as it depends on the findings during the first treatment session and the results of the previous treatment sessions. Thus, there are differences in the content of the individual treatments, but within the limits of the treatment protocol. The control group will not receive treatment, but are on a wait-and-see policy. They will be put on the waiting-list for three months. After three months of treatment the subjects will be followed for another nine months.
Intervention type	Other
Primary outcome measure	The overall score of the DASH (Disability of Arm Shoulder and Hand) questionnaire - Dutch language version will be used as the primary outcome measure. Timepoints: T0 = baseline T1 = 6 weeks later T2 = 12 weeks later T3 = 26 weeks T4 = 52 weeks
Secondary outcome measures	1. The total number of shoulder muscles with MTrPs will be counted and compared to the baseline measurement findings 2. Passive range of motion of the shoulder will be measured by an handheld digital inclinometer (The Saunders group Inc, Chaska, MN) 3. The total number of treatment sessions will be counted Timepoints: T0 = baseline T1 = 6 weeks later T2 = 12 weeks later T3 = 26 weeks T4 = 52 weeks
Overall study start date	01/09/2007
Completion date	01/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	52 patients per group
Total final enrolment	72
Key inclusion criteria	Between September 2007 and September 2008, all consecutive patients referred to a physical therapy practice specialised in the treatment of individuals with musculoskeletal disorders of the neck, shoulder and arm are potential study participants. The referring physicians include general practioners, orthopaedic surgeons, neurologists and physiatrists. Patients are eligible if they: 1. Have unilateral shoulder complaints (described as pain felt in the shoulder or upper arm) for at least six months 2. Present with persistent shoulder pain that has not spontaneously recovered 3. Are between 18 and 65 years old 4. Because the questionnaires are in the Dutch language, subjects must understand written and verbal Dutch
Key exclusion criteria	1. Diagnosed (prior to the referral) with: 1.1. Shoulder instability 1.2. Shoulder fractures 1.3. Systemic diseases (such as rheumatoid arthritis, Reiters syndrome, diabetes) 2. Medical history or examination suggests neurological diseases 3. Other severe medical or psychiatric disorders The project leader will check all the available information from referral letters, additional information from the general practitioner and from the patients.
Date of first enrolment	01/09/2007
Date of final enrolment	01/09/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Paulus Potterstraat 46

Groningen
9718 TK
Netherlands

Sponsor information

Radboud University Nijmegen Medical Centre (The Netherlands)
Hospital/treatment centre

Centre for Quality of Care Research
Research Centre for Allied Health Sciences
P.O. Box 9101
KWAZO 114
Nijmegen
6500 HB
Netherlands

Phone	+31 (0)50 312 0377
Email	c.bron@home.nl
Website	http://www.wokresearch.nl
"ROR"	https://ror.org/05wg1m734

Funders

Funder type

Hospital/treatment centre

All costs will be paid by the Private Practice for Physical Therapy Groningen and the Centre for Quality of Care Research, University Medical Centre Nijmegen (The Netherlands). The treatment sessions will be paid by the health insurance company.

No information available

External financing will be sought after the publication of the design paper.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	05/11/2007		Yes	No
Results article	results	24/01/2011	25/02/2021	Yes	No

Editorial Notes

25/02/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
06/11/2019: Internal review.