Achilles Tendon InjuryNCT02532595
TDN, Manual Therapy and Exercise For the Management of Achilles Tendinopathy
A study testing manual therapy and exercise and trigger point dry needling in people with Achilles Tendon Injury, run by Nova Southeastern University at 1 site in United States.
Trial summary
Conflicting evidence exists regarding the recommendations from the Orthopaedic section of the American Physical Therapy Association for treatment of Achilles tendinitis. Trigger point dry needling is effective in reducing pain in several body regions, but no published (TDN) studies are found reporting the effect on… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Achilles Tendon Injury
- What is being tested?
- manual therapy and exercise and trigger point dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pain onset greater than 4 weeks
- primary region of pain 2-6 cm proximal to the insertion on the calcaneus
- read and write in english
Who cannot join
- Fear of needles or unwilling to have needling performed due to fear or personal beliefs.
- Vascular or sensory disturbances in the lower leg which include but is not limited to injury to the nerve root or peripheral nerve in the affected lower leg, inflammatory diseases, bleeding or clotting disorders, lymphedema, peripheral vascular or peripheral arterial disease. Diabetes is included in this group due to the progressive changes to the sensation and circulation in the lower extremities.
- Recent infection.
- Previous surgery to the foot/ankle.
- Steroid by injection or transdermal delivery to the posterior heel within three months.
- Full rupture of the Achilles tendon.
- Pregnant or may be pregnant.
- Participants with a work related injury insured by the bureau of worker's compensation or involved in litigation related to injury of the lower leg, foot or ankle.
Trial locations and contacts
1 site in 1 country.
United States1 site
Breakthrough Physical Therapy
Fayetteville, North Carolina, 28311
About this study
Official title: Trigger Point Dry Needling, Manual Therapy and Exercise vs Manual Therapy and Exercise For the Management of Achilles Tendinopathy
Conflicting evidence exists regarding the recommendations from the Orthopaedic section of the American Physical Therapy Association for treatment of Achilles tendinitis. Trigger point dry needling is effective in reducing pain in several body regions, but no published (TDN) studies are found reporting the effect on Achilles tendinopathy. The purpose of this study is to investigate whether a treatment program performed including TDN, manual therapy and exercise will result in a significant improvement in pain, strength and function compared to a treatment program including manual therapy and exercise for Achilles tendinopathy. Subjects with Achilles tendinopathy that receive treatment including TDN, manual therapy and exercise will demonstrate a significant improvement in pain, strength and functional outcomes compared to the group that receives manual therapy and exercise.
Read the detailed description
This study is a randomized controlled trial, pretest-posttest control group design comparing the effect of TDN, manual therapy and exercise to manual therapy and exercise on human subjects with Achilles tendinopathy following eight treatments in four weeks and a follow up examination at three months.
- Conditions
- Achilles Tendon Injury
- Being tested
- manual therapy and exercise, trigger point dry needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual therapy and exerciseProcedure or surgery
soft tissue mobilization, stretches, concentric and eccentric strengthening
trigger point dry needlingProcedure or surgery
trigger point dry needling to trigger points located in the gastrocnemius, soleus and tibialis posterior
| Study group | Role | What they receive |
|---|---|---|
| Group 1 manual therapy and exercise | Active comparator | manual therapy with soft tissue mobilization to trigger points in the gastrocnemius, soleus, and tibialis posterior; exercise including stretching, concentric and eccentric exercises to the hip, triceps surae, tibialis posterior and foot intrinsics. Receives: Procedure: manual therapy and exercise |
| Group 2 TDN, manual therapy and exercise | Experimental | trigger point dry needling (TDN) to trigger points in the gastrocnemius, soleus and tibialis posterior; manual therapy with soft tissue mobilization to trigger points in the gastrocnemius, soleus, and tibialis posterior; exercise including stretching, concentric and eccentric exercises to the hip, triceps surae, tibialis posterior and foot intrinsics. Receives: Procedure: manual therapy and exercise; Procedure: trigger point dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure
Measured: 4 weeks
Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure
Measured: 3 months
Change in Pain from Baseline with the Numeric Pain Rating Scale
Measured: 4 weeks
Change in Pain from Baseline with the Numeric Pain Rating Scale
Measured: 3 months
Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia
Measured: 4 weeks
Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia
Measured: 3 months
Change in Pain from baseline with the Global Rating of Change
Measured: 4 weeks
Change in Pain from baseline with the Global Rating of Change
Measured: 3 months
Change in Pain from baseline with the Pain Pressure Threshold Measure
Primary site of pain on the Achilles tendon. All measurements taken with the Wagner FPK 20 Algometer.
Measured: 4 weeks
Change in Pain from baseline with the Pain Pressure Threshold Measure
Primary site of pain on the Achilles tendon. All measurements taken with the Wagner FPK 20 Algometer.
Measured: 3 months
Change in strength from baseline with the Muscle Endurance Test for single leg heel raise
Measured: 4 weeks
Change in strength from baseline with the Muscle Endurance Test for single leg heel raise
Measured: 3 months
Secondary outcomes (5)
Age
Demographic information -
Measured: baseline
Height
Demographic information
Measured: baseline
Weight
Demographic information
Measured: baseline
Gender
Demographic information
Measured: baseline
Duration of Pain
Demographic information
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startMay 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Achilles Tendon InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josh Cleland, DPT, PhD, Study chair, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532595
- Sponsor's protocol ID
- 03261504F
- Status last verified
- Jan 2020
- First submitted
- 14 Aug 2015
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Carcia CR, Martin RL, Houck J, Wukich DK; Orthopaedic Section of the American Physical Therapy Association. Achilles pain, stiffness, and muscle power deficits: achilles tendinitis. J Orthop Sports Phys Ther. 2010 Sep;40(9):A1-26. doi: 10.2519/jospt.2010.0305. No abstract available.
PubMed 20805627Ga H, Choi JH, Park CH, Yoon HJ. Dry needling of trigger points with and without paraspinal needling in myofascial pain syndromes in elderly patients. J Altern Complement Med. 2007 Jul-Aug;13(6):617-24. doi: 10.1089/acm.2006.6371.
PubMed 17718644Fernandez-Carnero J, La Touche R, Ortega-Santiago R, Galan-del-Rio F, Pesquera J, Ge HY, Fernandez-de-Las-Penas C. Short-term effects of dry needling of active myofascial trigger points in the masseter muscle in patients with temporomandibular disorders. J Orofac Pain. 2010 Winter;24(1):106-12.
PubMed 20213036Gonzalez-Iglesias J, Cleland JA, del Rosario Gutierrez-Vega M, Fernandez-de-las-Penas C. Multimodal management of lateral epicondylalgia in rock climbers: a prospective case series. J Manipulative Physiol Ther. 2011 Nov;34(9):635-42. doi: 10.1016/j.jmpt.2011.09.003. Epub 2011 Oct 21.
PubMed 22018577Tekin L, Akarsu S, Durmus O, Cakar E, Dincer U, Kiralp MZ. The effect of dry needling in the treatment of myofascial pain syndrome: a randomized double-blinded placebo-controlled trial. Clin Rheumatol. 2013 Mar;32(3):309-15. doi: 10.1007/s10067-012-2112-3. Epub 2012 Nov 9.
PubMed 23138883Cotchett MP, Munteanu SE, Landorf KB. Effectiveness of trigger point dry needling for plantar heel pain: a randomized controlled trial. Phys Ther. 2014 Aug;94(8):1083-94. doi: 10.2522/ptj.20130255. Epub 2014 Apr 3.
PubMed 24700136Llamas-Ramos R, Pecos-Martin D, Gallego-Izquierdo T, Llamas-Ramos I, Plaza-Manzano G, Ortega-Santiago R, Cleland J, Fernandez-de-Las-Penas C. Comparison of the short-term outcomes between trigger point dry needling and trigger point manual therapy for the management of chronic mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Nov;44(11):852-61. doi: 10.2519/jospt.2014.5229. Epub 2014 Sep 30.
PubMed 25269764Osborne NJ, Gatt IT. Management of shoulder injuries using dry needling in elite volleyball players. Acupunct Med. 2010 Mar;28(1):42-5. doi: 10.1136/aim.2009.001560.
PubMed 20351377Jayaseelan DJ, Moats N, Ricardo CR. Rehabilitation of proximal hamstring tendinopathy utilizing eccentric training, lumbopelvic stabilization, and trigger point dry needling: 2 case reports. J Orthop Sports Phys Ther. 2014 Mar;44(3):198-205. doi: 10.2519/jospt.2014.4905. Epub 2013 Nov 21.
PubMed 24261928Koszalinski A, Flynn T, Hellman M, Cleland JA. Trigger point dry needling, manual therapy and exercise versus manual therapy and exercise for the management of Achilles tendinopathy: a feasibility study. J Man Manip Ther. 2020 Sep;28(4):212-221. doi: 10.1080/10669817.2020.1719299. Epub 2020 Feb 12.
PubMed 32048918
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trigger Point Dry Needling, Manual Therapy and Exercise vs Manual Therapy and Exercise For the Management of Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT02532595
- Acronym / sponsor ID
- 03261504F
- Conditions
- Achilles Tendon Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conflicting evidence exists regarding the recommendations from the Orthopaedic section of the American Physical Therapy Association for treatment of Achilles tendinitis. Trigger point dry needling is effective in reducing pain in several body regions, but no published (TDN) studies are found reporting the effect on Achilles tendinopathy. The purpose of this study is to investigate whether a treatment program performed including TDN, manual therapy and exercise will result in a significant improvement in pain, strength and function compared to a treatment program including manual therapy and exercise for Achilles tendinopathy. Subjects with Achilles tendinopathy that receive treatment including TDN, manual therapy and exercise will demonstrate a significant improvement in pain, strength and functional outcomes compared to the group that receives manual therapy and exercise.
Detailed description
This study is a randomized controlled trial, pretest-posttest control group design comparing the effect of TDN, manual therapy and exercise to manual therapy and exercise on human subjects with Achilles tendinopathy following eight treatments in four weeks and a follow up examination at three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 manual therapy and exercise | Active comparator | Procedure: manual therapy and exercisemanual therapy with soft tissue mobilization to trigger points in the gastrocnemius, soleus, and tibialis posterior; exercise including stretching, concentric and eccentric exercises to the hip, triceps surae, tibialis posterior and foot intrinsics. |
| Group 2 TDN, manual therapy and exercise | Experimental | Procedure: manual therapy and exercise, Procedure: trigger point dry needlingtrigger point dry needling (TDN) to trigger points in the gastrocnemius, soleus and tibialis posterior; manual therapy with soft tissue mobilization to trigger points in the gastrocnemius, soleus, and tibialis posterior; exercise including stretching, concentric and eccentric exercises to the hip, triceps surae, tibialis posterior and foot intrinsics. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pain onset greater than 4 weeks
- primary region of pain 2-6 cm proximal to the insertion on the calcaneus
- read and write in english
Key exclusion criteria (8 listed)
- Fear of needles or unwilling to have needling performed due to fear or personal beliefs.
- Vascular or sensory disturbances in the lower leg which include but is not limited to injury to the nerve root or peripheral nerve in the affected lower leg, inflammatory diseases, bleeding or clotting disorders, lymphedema, peripheral vascular or peripheral arterial disease. Diabetes is included in this group due to the progressive changes to the sensation and circulation in the lower extremities.
- Recent infection.
- Previous surgery to the foot/ankle.
- Steroid by injection or transdermal delivery to the posterior heel within three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manual therapy and exercisesoft tissue mobilization, stretches, concentric and eccentric strengthening | Procedure or surgery | Group 1 manual therapy and exercise, Group 2 TDN, manual therapy and exercise |
| trigger point dry needlingtrigger point dry needling to trigger points located in the gastrocnemius, soleus and tibialis posterior | Procedure or surgery | Group 2 TDN, manual therapy and exercise |
Primary outcome
Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure
Time frame: 4 weeks
Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure
Time frame: 3 months
Change in Pain from Baseline with the Numeric Pain Rating Scale
Time frame: 4 weeks
Change in Pain from Baseline with the Numeric Pain Rating Scale
Time frame: 3 months
Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia
Time frame: 4 weeks
Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia
Time frame: 3 months
Change in Pain from baseline with the Global Rating of Change
Time frame: 4 weeks
Change in Pain from baseline with the Global Rating of Change
Time frame: 3 months
Change in Pain from baseline with the Pain Pressure Threshold Measure
Time frame: 4 weeks
Primary site of pain on the Achilles tendon. All measurements taken with the Wagner FPK 20 Algometer.
Change in Pain from baseline with the Pain Pressure Threshold Measure
Time frame: 3 months
Primary site of pain on the Achilles tendon. All measurements taken with the Wagner FPK 20 Algometer.
Change in strength from baseline with the Muscle Endurance Test for single leg heel raise
Time frame: 4 weeks
Change in strength from baseline with the Muscle Endurance Test for single leg heel raise
Time frame: 3 months
5 secondary outcomes
Age
Time frame: baseline
Height
Time frame: baseline
Weight
Time frame: baseline
Gender
Time frame: baseline
Duration of Pain
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Background: PubMed 20805627Carcia CR, Martin RL, Houck J, Wukich DK; Orthopaedic Section of the American Physical Therapy Association. Achilles pain, stiffness, and muscle power deficits: achilles tendinitis. J Orthop Sports Phys Ther. 2010 Sep;40(9):A1-26. doi: 10.2519/jospt.2010.0305. No abstract available.
- Background: PubMed 17718644Ga H, Choi JH, Park CH, Yoon HJ. Dry needling of trigger points with and without paraspinal needling in myofascial pain syndromes in elderly patients. J Altern Complement Med. 2007 Jul-Aug;13(6):617-24. doi: 10.1089/acm.2006.6371.
- Background: PubMed 20213036Fernandez-Carnero J, La Touche R, Ortega-Santiago R, Galan-del-Rio F, Pesquera J, Ge HY, Fernandez-de-Las-Penas C. Short-term effects of dry needling of active myofascial trigger points in the masseter muscle in patients with temporomandibular disorders. J Orofac Pain. 2010 Winter;24(1):106-12.
- Background: PubMed 22018577Gonzalez-Iglesias J, Cleland JA, del Rosario Gutierrez-Vega M, Fernandez-de-las-Penas C. Multimodal management of lateral epicondylalgia in rock climbers: a prospective case series. J Manipulative Physiol Ther. 2011 Nov;34(9):635-42. doi: 10.1016/j.jmpt.2011.09.003. Epub 2011 Oct 21.
- Background: PubMed 23138883Tekin L, Akarsu S, Durmus O, Cakar E, Dincer U, Kiralp MZ. The effect of dry needling in the treatment of myofascial pain syndrome: a randomized double-blinded placebo-controlled trial. Clin Rheumatol. 2013 Mar;32(3):309-15. doi: 10.1007/s10067-012-2112-3. Epub 2012 Nov 9.
- Background: PubMed 24700136Cotchett MP, Munteanu SE, Landorf KB. Effectiveness of trigger point dry needling for plantar heel pain: a randomized controlled trial. Phys Ther. 2014 Aug;94(8):1083-94. doi: 10.2522/ptj.20130255. Epub 2014 Apr 3.
- Background: PubMed 25269764Llamas-Ramos R, Pecos-Martin D, Gallego-Izquierdo T, Llamas-Ramos I, Plaza-Manzano G, Ortega-Santiago R, Cleland J, Fernandez-de-Las-Penas C. Comparison of the short-term outcomes between trigger point dry needling and trigger point manual therapy for the management of chronic mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Nov;44(11):852-61. doi: 10.2519/jospt.2014.5229. Epub 2014 Sep 30.
- Background: PubMed 20351377Osborne NJ, Gatt IT. Management of shoulder injuries using dry needling in elite volleyball players. Acupunct Med. 2010 Mar;28(1):42-5. doi: 10.1136/aim.2009.001560.
- Background: PubMed 24261928Jayaseelan DJ, Moats N, Ricardo CR. Rehabilitation of proximal hamstring tendinopathy utilizing eccentric training, lumbopelvic stabilization, and trigger point dry needling: 2 case reports. J Orthop Sports Phys Ther. 2014 Mar;44(3):198-205. doi: 10.2519/jospt.2014.4905. Epub 2013 Nov 21.
- Derived from this study: PubMed 32048918Koszalinski A, Flynn T, Hellman M, Cleland JA. Trigger point dry needling, manual therapy and exercise versus manual therapy and exercise for the management of Achilles tendinopathy: a feasibility study. J Man Manip Ther. 2020 Sep;28(4):212-221. doi: 10.1080/10669817.2020.1719299. Epub 2020 Feb 12.
Related trials for Achilles Tendon Injury
Not yet recruitingObservational study
Human Tendon Tissue Collection
Tendinopathy, Musculoskeletal Diseases or Conditions
Not yet recruiting
Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
Achilles Injuries Tendon, Achilles Tendinopathy (AT)
Recruiting
Autologous Fat Grafting for the Treatment of Chronic Tendinopathy
Chronic Tendinopathy
RecruitingObservational study
Achilles Tendon Rupture Patient Outcomes at 12 Months
Achilles Tendon Rupture
RecruitingObservational study
GOAT (Gait Observation of Achilles Tendon)
Spastic Paresis, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josh Cleland, DPT, PhD study chair
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual therapy and exercise and trigger point dry needling in people with Achilles Tendon Injury, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure (time frame: 4 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02532595, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.