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Trial registered on ANZCTR


Registration number
ACTRN12616000902493
Ethics application status
Approved
Date submitted
24/05/2016
Date registered
7/07/2016
Date last updated
7/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Progressive Pressure Release Versus Dry Needling on Cervical Latent Trigger Points
Scientific title
Progressive Pressure Release Versus Dry Needling on Cervical Latent Trigger Points
Secondary ID [1] 289283 0
Nil known
Universal Trial Number (UTN)
U1111-1183-1421
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Latent myofascial trigger points 298866 0
Condition category
Condition code
Musculoskeletal 298938 298938 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 298939 298939 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study was conducted at the out patient clinic of faculty of Physical Therapy, Cairo University , Egypt. After signing an informed consent form, thirty subjects with latent myofascial trigger points (L-MTrPs) were assigned into two equal groups; (A) 15 subjects received passive stretching and progressive pressure release; 3 times per week for 4 weeks. Group (B) 15 subjects received passive stretching exercise and dry needling using acupuncture needles, 3 times per week for 4 weeks..

A certified physical therapist with more that 7 years experience carried out the assessment procedure. Clinical identification of L-MTrPs was based on Travel and Simon (1999) essential criteria, where the upper trapezius was placed in a stretched and relaxed position to easily locate L-MTrPs. Flat or pincer palpation was used to locate L-MTrPs.
Essential criteria for L-MTrPs included;
1- Palpable taut band: which includes a tender nodule.
2- Exquisite spot tenderness of a nodule: Palpating through a taut band, there was a tender nodular area.
3- Limited range of motion at the end of range: it is a common characteristic of myofascial trigger points to restrict the range of motion and produce pain at the end of range (Fernndez et al., 2007 and Mullaney et al., 2010).
He then marked an "X" on the L-MTrPs found, that were;
L-MTrP1: was found in the mid portion of the anterior border of the upper trapezius and involves the most vertical fibers that attach anteriorly to the clavicle.
L-MTrP2: lies caudal and slightly lateral to L-MTrP1 which was located in the middle of the more nearly-horizontal fibers of the upper trapezius

Measurement outcome included pressure pain threshold using an electronic digital algometer and active cervical side bending and rotation using an inclinometer. Measurements were taken at the first treatment as baseline measurement and the end of the 4 weeks trial; at the last session as post-test measurement. Each subject had a sheet, where outcome measures were recorded in as well as attendance of sessions was registered in.

Another certified physical therapist with 5 years experience carried out the progressive pressure release on the marked "X" L-MTrP and passive stretch treatment procedure. Passive stretch was applied while the patient was in seated position, the head was then taken to flexion, side bending to the opposite side and rotation to the same side, this position was maintained for 30-60 seconds and repeated 3 times. Progressive pressure release technique was applied using the thumbs; steady pressure was applied, moving inward toward the center. Once tissue resistance was felt, we stopped and waited until resistance dissipated, and then when a slow release or a "melting away" sensation of the tissue under treating fingers was felt, further steady pressure moving again inward toward the center was applied for 2-3 minutes. This was repeated 4 times. The muscle was placed in a position to maximize stretch, but in a relaxed one.

A third certified acupuncture therapist applied the dry needling treatment procedure. where patients were placed in a comfortable sitting position and encouraged to maintain complete relaxation. The selected L-MTrP (marked by an "X") was prepared by wiping the area with an alcohol pad, and an acupuncture needle with its plastic guide tube in place was placed over the L-MTrP. With pincer palpation, the needle was applied to a depth of 1-1.5 cm. Needle movement was performed with rotation along its long axis in an effort till eliciting a small muscle twitch around the nodule; a local twitch response, which took from 30 sec to 2 min then the needle was removed.
Intervention code [1] 294830 0
Treatment: Devices
Intervention code [2] 294831 0
Treatment: Other
Intervention code [3] 294832 0
Rehabilitation
Comparator / control treatment
Comparator treatment was Group (B); that received passive stretching and dry needling using acupuncture needles, 3 times per week for 4 weeks..
Control group
Active

Outcomes
Primary outcome [1] 298407 0
pain pressure threshold by electronic digital algometer
Timepoint [1] 298407 0
prior to the first treatment session and as baseline measurement and the end of the 4 weeks trial; at the last session as post-test measurement.
Secondary outcome [1] 324045 0
Active range of motion including cervical side bending and rotation was taken by a single inclinometer.
Timepoint [1] 324045 0
Measurements were taken at the first treatment as baseline measurement and the end of the 4 weeks trial; at the last session as post-test measurement.

Eligibility
Key inclusion criteria
1. Subjects with age ranging from 20 to 30 years old (Edwards, et al., 2003)
2. Subjects haven’t experienced any neck pain for at least 3 months.
3. Presence of at least one latent MTrPs in the upper trapezius muscle (on the dominant side) and the production of pain by palpation on MTrPs.
4. Limitation in cervical side bending and rotation at the end of range.
Minimum age
20 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any inflammatory diseases of musculoskeletal system.
2. Patients with cervical pain or neurological deficit (radiating pain, loss of sensation, muscle dysfunction, or loss of reflexes), disc prolapse, , previous neck surgery, and other
3. Cardiopulmonary diseases which decreases the patient’s tolerance and activities.
4. Vascular problems.
5. Patient with uncontrolled diabetes.
6. Neck pain due to unknown cause.
7. Any dermatological diseases.
8. Any deformity of the spine e.g.: sever scoliosis or kyphosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Results are expressed as mean +/- standard deviation (SD). Data are normally distributed, so comparison between different variables in the two studied groups was performed using unpaired t test. Pair-wise comparison (pre- versus post-assessment) within the same group for different variables was performed using paired t-test.
Statistical Package for Social Sciences (SPSS) computer program (version 19 windows) was used for data analysis. P value less than 0.05 was considered significant and less than 0.01 was considered highly significant.

Sample size calculation: since our design had paired observations (before-and-after), assuming its just a one-group test where each subject is serving as his/her own control. The study participants were assigned into two homogenous treatment groups. The patients in the first treatment group were given progressive pressure release and those in the second group B were given acupuncture dry needling. The primary endpoint is taken as the mean increase in pressure pain threshold after four weeks. Clinical knowledge suggests that the standard deviation of the increase in pressure pain threshold with both treatments can be taken as 4.5 kgf.
A one-tailed t-test for unpaired samples was performed. The level of significance was set at 2.5% for one-tailed test. The statistical power was set as 80%.

Effect size was computed using Cohen's d and Hedges g that was 2.78 given group a mean & SD (10.48 +/- 1.21) and group b (7.48+/- 0.93) with a sample size of 15 subjects per group

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/01/2015
Date of last participant enrolment
Anticipated
Actual
4/04/2015
Date of last data collection
Anticipated
Actual
4/05/2015
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 7893 0
Egypt
State/province [1] 7893 0
cairo

Funding & Sponsors
Funding source category [1] 293660 0
Self funded/Unfunded
Name [1] 293660 0
Mary Takla
Country [1] 293660 0
Egypt
Primary sponsor type
University
Name
Faculty of Physical therapy, Cairo University
Address
El-Tahrir street. in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432
Country
Egypt
Secondary sponsor category [1] 292593 0
None
Name [1] 292593 0
Address [1] 292593 0
Country [1] 292593 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295097 0
The Board Council ofHigher Education of the School of Physical Therapy
Ethics committee address [1] 295097 0
Ethics committee country [1] 295097 0
Egypt
Date submitted for ethics approval [1] 295097 0
01/06/2014
Approval date [1] 295097 0
01/07/2014
Ethics approval number [1] 295097 0
Ethics committee name [2] 295098 0
Institutional Review Board of Higher Education and Research of Cairo University
Ethics committee address [2] 295098 0
Ethics committee country [2] 295098 0
Egypt
Date submitted for ethics approval [2] 295098 0
03/07/2014
Approval date [2] 295098 0
03/08/2014
Ethics approval number [2] 295098 0
Ethics committee name [3] 295099 0
Supreme Council of Universities at Egypt
Ethics committee address [3] 295099 0
Ethics committee country [3] 295099 0
Egypt
Date submitted for ethics approval [3] 295099 0
04/08/2014
Approval date [3] 295099 0
04/09/2014
Ethics approval number [3] 295099 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66114 0
Dr Mary Kamal Nassif Takla
Address 66114 0
School of Physical therapy, Cairo University; El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432
Country 66114 0
Egypt
Phone 66114 0
+201222817512
Fax 66114 0
Email 66114 0
marytakla@hotmail.com
Contact person for public queries
Name 66115 0
Mary Kamal Nassif Takla
Address 66115 0
School of Physical therapy, Cairo University; El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432
Country 66115 0
Egypt
Phone 66115 0
+201222817512
Fax 66115 0
Email 66115 0
marytakla@hotmail.com
Contact person for scientific queries
Name 66116 0
Mary Kamal Nassif Takla
Address 66116 0
School of Physical therapy, Cairo University; El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432
Country 66116 0
Egypt
Phone 66116 0
+201222817512
Fax 66116 0
Email 66116 0
marytakla@hotmail.com

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Results publications and other study-related documents

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