Trigger point dry needling, manual therapy and exercise versus manual therapy and exercise for the management of Achilles tendinopathy: a feasibility study

Author Names

Koszalinski, A., Flynn, T., Hellman, M., Cleland, J.A.

Reviewer Name

Payton Bellows, SPT

Reviewer Affiliation(s)

Duke University Doctor of Physical Therapy Division

 

Paper Abstract

Objectives The effects of trigger point dry needling (TDN) on myofascial trigger points (MTP) in Achilles tendinopathy (AT) are unknown. We conducted a study to test the feasibility of a large randomized controlled trial (RCT) to compare the effects of TDN to MT and exercise in a patient population with AT.  Methods Twenty-two subjects were randomly assigned to a control (MT+Ex) or experimental group (TDN+MT+Ex) and completed eight treatment sessions over 4 weeks with follow up at 3 months. TDN was performed to MTPs in the gastrocnemius, soleus or tibialis posterior each session. The same MT and exercise program was conducted in both groups.  Results Two of three criteria for feasibility were met. The attrition rate at 4-week and 3-month follow-up was 18.1% and 68%, respectively. Significant differences (p < .05) reported for within group analysis for FAAM, NPRS, pain pressure threshold and strength in both groups at 4 weeks and 3 months. The GROC was significant for MT + Ex at 3 months. No between group differences were found.  The MCID for the FAAM, GROC was surpassed in both groups at 4 weeks and 3 months and NPRS for the MT + Ex group at 4 weeks.  Discussion A large RCT to investigate the effects of TDN on MTP in AT is not feasible without modifications due to low recruitment and high attrition rate. Modifications to study design should give consideration for closed or national health-care system for access to large patient populations and reduced financial burden to subjects.  Trial Registration ClinicalTrials.gov identifier: NCT03261504F.  KEYWORDS: Trigger point dry needling, myofascial trigger points, feasibility, Achilles, eccentric

 

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT

• Yes

2. Was the method of randomization adequate (i.e., use of randomly generated assignment)?

• Yes

3. Was the treatment allocation concealed (so that assignments could not be predicted)?

• Yes

4. Were study participants and providers blinded to treatment group assignment?

• Yes

5. Were the people assessing the outcomes blinded to the participants’ group assignments?

• No

6. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?

• Yes

7. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?

• No

8. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?

• Yes

9. Was there high adherence to the intervention protocols for each treatment group?

• Yes

10. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?

• Yes

11. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?

• Yes

12. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?

• No

13. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?

• No

14. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?

• Yes

 

Key Finding #1

The MDIC of the global rating of change (GROC) was met and exceeded for both the (MT+Ex) and (TDN+MT+Ex) groups. This indicates improvement for patients who received manual therapy.

Key Finding #2

The results of the study were overshadowed by low recruitment and retention. Low recruitment of patients to RTC were due to factors such as aversions to needles, time commitment, and finances. Low retention due to no further incentive to return at 3 months  after their pain was reduced with the 4 week treatments.

Key Finding #3

Post- treatment soreness was commonly reported in both (MT+Ex) and (TDN+MT+Ex).

Key Finding #4

Significant improvements where shown clinically for pain, strength, and functional outcomes but both (MT+Ex) and (TDN+MT+Ex).

 

Please provide your summary of the paper

The randomized control trial showed that a combination of manual therapy and exercise (MT+Ex), and trigger point dry needling, manual therapy, and exercise (TDN+MT+Ex) resulted in a significant improvements for pain, strength, and functional outcomes. This study included 22 participants over a 3 year period (May 2015-Aug 2018) in 7 private outpatient clinics across North Carolina, Tennessee, and Iowa with different physical therapists providing treatments. The manual therapy and exercise treatments were kept consistent for the 2 groups throughout the 4 weeks and 8 sessions. FAAM, NPRS, GROC, pain pressure threshold and strength were all used to measure the significant changes at 4 weeks and 3 months. No differences were found between the two groups, but the MCID was exceeded with the FAAM, GROC, and NPRS at 4 weeks and 3 months. This study was not a large RTC due to low recruitment and high attrition rate. The low recruitment was due to the inclusion criteria (which was altered after the first year), raising out-of-pocket costs and changes in referring provider health system network, along with other barriers to participation such as needle aversion and time commitment. This study showed that a large RCT was not feasible due to the inability to meet the primary and secondary objectives of the study. Recommendations were given to aid in the replications of the study to provide a feasible large RCT.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

This study can impact clinical practice if replicated with a large RTC to investigate the effect of trigger point dry needling with manual therapy and exercise on pain and functional outcome compared to just manual therapy and exercise. While the study was deemed not feasible, there are currently no published literature that investigates the effects of TDN for myofascial trigger points in Achilles tendinopathy. This study can help contribute to reduced rates of Achilles tendinopathy and Achilles rupture with appropriate treatment methods of tendinopathy prior to rupture. Current studies have shown that eccentric strengthening is effective for the healing response in tendons with slow gradual improvements over a 4-5 year period. Myofascial trigger points have shorter healing times than eccentric exercises. The study demonstrated that manual therapy techniques are best implemented alongside exercise for the clinical improvement of pain, strength, and functional outcomes in Achilles tendinopathy.