Manipulation & Dry Needling vs. Mobilization & Massage for Tension Headaches

Overseen By James Dunning, DPT PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alabama Physical Therapy & Acupuncture

Must not be taking: Headache medications

Disqualifiers: Other headaches, Head/neck trauma, Atherosclerotic risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial will compare two treatment methods for individuals with tension-type headaches. One method includes thrust manipulation, electric dry needling, and exercise, while the other involves non-thrust mobilization, soft-tissue mobilization, exercise, and TENS (a form of electronic nerve stimulation). The trial aims to determine which method more effectively relieves these headaches. Individuals with frequent tension-type headaches that meet specific criteria, such as headaches that do not worsen with physical activity, may qualify for this trial. As an unphased trial, it provides participants the chance to contribute to valuable research that may enhance headache treatment options.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a Medication Overuse Headache, you would be excluded from the trial.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a Medication Overuse Headache, you would not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments like thrust manipulation and electric dry needling, when combined with exercise, have been tested in people with headaches. Studies have found that this combination significantly reduces headache severity, frequency, and duration. Few reports of serious side effects suggest that most people handle these treatments well.

For the other approach, which includes non-thrust mobilization, soft-tissue mobilization, exercise, and TENS (a therapy using electrical currents), studies have also tested these methods for headache relief. Physical therapists widely use these treatments, and they are generally considered safe. Most people tolerate them without major issues.

Both treatment options compared in this trial have been used in people with similar problems. While specific safety data for tension-type headaches might not be detailed, these treatments are commonly practiced, suggesting a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for tension headaches because they explore different manual therapy and needling techniques that might offer new benefits beyond standard care. Unlike the usual medications and lifestyle adjustments, non-thrust mobilization paired with soft-tissue techniques and TENS (Transcutaneous Electrical Nerve Stimulation) could provide a non-invasive approach to pain relief. Meanwhile, thrust manipulation combined with electric dry needling and exercise might offer a novel way to address muscle tension and trigger points more directly. These approaches could potentially offer faster or more sustainable relief by targeting the physical sources of tension headaches in a new way.

What evidence suggests that this trial's treatments could be effective for tension headaches?

In this trial, participants will be assigned to one of two treatment arms. Research has shown that a combination of thrust manipulation and electric dry needling, which participants in one arm may receive, can greatly reduce pain and disability from tension-type headaches. One study found that this method led to better pain relief and less need for medication. Dry needling also decreased headache frequency and improved overall quality of life.

Alternatively, participants in the other arm will receive non-thrust mobilization and TENS, a treatment using mild electrical currents to relieve pain. Previous research has shown that TENS reduced headache severity, though it was slightly less effective overall compared to other methods, with about 64.5% of people responding well. Both treatments are commonly used by physical therapists and have shown positive results in earlier studies. ^{1 6 7 8 9}

Who Is on the Research Team?

James Dunning, DPT PhD

Principal Investigator

American Academy of Manipulative Therapy

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with frequent episodic or chronic tension-type headaches and tenderness around the head. Participants must not have had recent neck/head treatments, surgery, trauma, or conditions like fibromyalgia. Pregnant individuals or those involved in related litigation are excluded.

Inclusion Criteria

I have frequent headaches with scalp tenderness.

I experience tension-type headaches.

I have frequent or chronic tension headaches.

Exclusion Criteria

I have at least two signs of nerve damage due to pressure on my nerves.

I have symptoms in both of my arms.

I have had surgery on my neck or upper back.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive either thrust manipulation, electric dry needling, and exercise or non-thrust mobilization, soft-tissue mobilization, exercise, and TENS for tension-type headaches

6 weeks

2 sessions per week

Follow-up

Participants are monitored for changes in headache intensity, disability, frequency, and duration

6 weeks

Assessments at 4, 8, and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS
• Thrust Manipulation, Electric Dry Needling and Exercise

Trial Overview The study compares two headache treatment methods: one combines thrust manipulation, electric dry needling and exercise; the other uses non-thrust mobilization, soft-tissue work, exercise and TENS (a type of electrical nerve stimulation).

How Is the Trial Designed?

Group I: thrust manipulation, electric dry needling and exercise Experimental Treatment 1 Intervention

thrust manipulation, electric dry needling and exercise

Group II: non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS Active Control 1 Intervention

non-thrust mobilization, soft-tissue mobilization, exercise and TENS

Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Physical Therapy Modalities for:

• Tension-type headaches
• Musculoskeletal pain
• Rehabilitation

Approved in European Union as Physical Therapy Modalities for:

• Tension-type headaches
• Musculoskeletal disorders
• Pain management

Approved in Canada as Physical Therapy Modalities for:

• Tension-type headaches
• Musculoskeletal injuries
• Chronic pain

Who Is Running the Clinical Trial?

Alabama Physical Therapy & Acupuncture

Lead Sponsor

Trials

15

Recruited

2,200+

Universidad Rey Juan Carlos

Collaborator

Trials

137

Recruited

10,300+

Published Research Related to This Trial

Three studies indicated that dry needling, when added to conventional physiotherapy, resulted in statistically significant improvements in tension-type and cervicogenic headaches, particularly noting a 45 mm reduction in pain intensity on the VAS scale.

While no significant differences were found between groups, and no adverse events were reported, the evidence suggests that dry needling could be a beneficial adjunct to physiotherapy for headache management, warranting further research for stronger conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for the use of dry needling and physiotherapy in the management of cervicogenic or tension-type headache: a systematic review. France, S., Bown, J., Nowosilskyj, M., et al.[2022]

The dry-needle technique showed significant improvements in muscle tenderness and neck range of motion (ROM) in patients with tension-type headache (TTH), indicating potential benefits beyond just pain relief.

However, while both the treatment and placebo groups reported reduced headache indices, the difference between them was not statistically significant, suggesting that further research is needed to confirm the efficacy of this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 'dry-needle technique': intramuscular stimulation in tension-type headache. Karakurum, B., Karaalin, O., Coskun, O., et al.[2017]

A systematic review included 12 randomized controlled trials with 919 participants to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) for treating acute pain, but insufficient data prevented definitive conclusions.

The review highlighted that many studies were excluded because TENS was used alongside other treatments, indicating a need for more focused research on TENS as a standalone therapy for acute pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for acute pain. Walsh, DM., Howe, TE., Johnson, MI., et al.[2022]

Physiotherapy methods for 'soft E.N.T. treatment' focus on gentle techniques like relaxation, bio-feedback, and massage to promote recovery without causing additional stress to the patient.

These techniques have been successfully used to treat various conditions, including headaches, migraines, vertigo, and temporo-mandibular joint problems, highlighting their efficacy in restoring optimal function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercise therapy in E.N.T]. Leduc, A., Decloedt, V.[2009]

In a study involving 97 patients with frequent episodic tension-type headache (FETTH) or chronic tension-type headache (CTTH), a combination of soft tissue and neural mobilization techniques significantly improved pain thresholds and reduced headache frequency and intensity compared to placebo and isolated treatments.

The combination treatment group showed the most substantial benefits, indicating that using both techniques together is more effective for managing tension-type headaches than using either technique alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Treatment Involving Soft Tissue Techniques and/or Neural Mobilization Techniques in the Management of Tension-Type Headache: A Randomized Controlled Trial. Ferragut-Garcías, A., Plaza-Manzano, G., Rodríguez-Blanco, C., et al.[2022]

In a double-blind trial with 62 participants suffering from chronic low back pain, TENS significantly reduced pain intensity compared to sham-TENS, with effects lasting up to 24 hours after treatment.

Despite the pain relief observed, there were no significant changes in plasma levels of beta-endorphin or met-enkephalin, suggesting that the mechanism of action for TENS may not involve these specific pain-relief hormones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation effects on pain-intensity and endogenous opioids levels among chronic low-back pain patients: A randomised controlled trial. Ezema, CI., Onyeso, OK., Nna, EO., et al.[2022]

In a study of 70 patients with cervicogenic headache, manipulation treatment significantly reduced headache severity, frequency, and duration after 40 days, showing a high response rate of 94.5%.

Transcutaneous electrical nerve stimulation (TENS) also reduced headache severity but was less effective overall, with a response rate of only 64.5%, indicating that manipulation may be a more effective treatment option for this type of headache.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparative study on effects of manipulation treatment and transcutaneous electrical nerve stimulation on patients with cervicogenic headache]. Li, C., Zhang, XL., Ding, H., et al.[2019]

In a study of 50 patients with neck pain from myofascial trigger points, both dry needling (DN) and transcutaneous electrical nerve stimulation (TENS) significantly reduced pain and improved neck function over 28 days, as measured by the Visual Analog Scale (VAS) and Neck Disability Index (NDI).

Dry needling was found to be more effective than TENS in reducing pain intensity, making it a more beneficial and cost-effective treatment option, while TENS showed better results in improving cervical rotation to the painful side.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Dry Needling Versus Transcutaneous Electrical Nerve Stimulation in Patients With Neck Pain Due to Myofascial Trigger Points: A Randomized Controlled Trial. G, A., Gupta, AK., Kumar, D., et al.[2023]

This study will evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) in reducing movement-evoked pain in 600 individuals with fibromyalgia, using a randomized cluster design across multiple physical therapy clinics.

The primary outcome will measure pain reduction over 60 days, providing valuable data on TENS as a nonpharmacological treatment option for fibromyalgia, which could influence healthcare policies and future research on chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded Pragmatic Trial. Post, AA., Dailey, DL., Bayman, EO., et al.[2023]

A single session of burst-type transcutaneous electrical nerve stimulation (TENS) significantly increased the pressure pain threshold over latent myofascial trigger points in the upper trapezius muscle, indicating improved pain sensitivity.

TENS also resulted in a small but significant increase in cervical range of motion, suggesting that this treatment may help enhance mobility in individuals with latent trigger points.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of burst-type transcutaneous electrical nerve stimulation on cervical range of motion and latent myofascial trigger point pain sensitivity. Rodríguez-Fernández, AL., Garrido-Santofimia, V., Güeita-Rodríguez, J., et al.[2022]

In a study involving 144 healthy participants aged 18 to 30, the combination of transcutaneous electrical nerve stimulation (TENS) and cervical joint manipulation (JM) resulted in significantly greater pain relief compared to either treatment used alone.

Both segmental (local) and extrasegmental (widespread) pain relief were enhanced when TENS and JM were combined, indicating that these treatments can work synergistically to improve hypoalgesic effects in asymptomatic individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoalgesic Effects of Transcutaneous Electrical Nerve Stimulation Combined With Joint Manipulation: A Randomized Clinical Trial. Telles, JD., Schiavon, MAG., Costa, ACS., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-headache-6-2020-2c370

Manipulation & Dry Needling vs. Mobilization & Massage ... Transcutaneous electrical nerve stimulation (TENS) also reduced headache severity but was less effective overall, with a response rate of only 64.5 ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04609709/hvlat-electric-dn-exercise-vs-mobilization-stm-exercise-tens-for-tension-type-headaches

HVLAT, Electric DN, Exercise Vs. Mobilization, STM, ... The purpose of this research is to compare two different approaches for treating patients with tension-type headaches: thrust Manipulation, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5975046/

Effectiveness of transcutaneous electrical nerve stimulation for ... This meta-analysis suggests that TENS may serve as an effective and well-tolerated alternative for migraineurs.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161475422001373

Effects of Transcutaneous Occipital Nerve Stimulation and ... IASTM and TONS applications reduced head and neck pain and improved sleep and quality of life in patients with chronic migraine.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04609709

HVLAT, Electric DN, Exercise Vs. Mobilization, STM ... The purpose of this research is to compare two different approaches for treating patients with tension-type headaches: thrust Manipulation, electric dry ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12123087/

Comparative safety and efficacy of manual therapy ... To evaluate and compare the safety and efficacy of spinal manipulation, mobilization, and massage for the management of cervicogenic headache ( ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11421161/

The majority of clinical trials assessing mobilization and ... Joint mobilization and manipulation have been shown to be an effective treatment for neck pain. However, the generalizability and clinical translation depends ...

8. jospt.org jospt.org/doi/10.2519/jospt.2018.7476

Unraveling the Mechanisms of Manual Therapy: Modeling ... In this clinical commentary, we provide a narrative appraisal of the model and recommendations to advance the study of manual therapy mechanisms.

9. physio-pedia.com physio-pedia.com/Manual_Therapy

Manual Therapy An advanced specialty area of physical therapy practice that is based on manual examination and treatment techniques integrated with exercise, patient ...