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

Trial Summary

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.

What data supports the idea that Manipulation & Dry Needling vs. Mobilization & Massage for Tension Headaches is an effective treatment?

The available research shows that both Manipulation & Dry Needling and Mobilization & Massage can be effective treatments for tension headaches. One study found that soft tissue techniques and neural mobilization techniques, which are similar to Mobilization & Massage, were effective in managing tension-type headaches. Additionally, another study comparing dry needling and transcutaneous electrical nerve stimulation (TENS) for neck pain, which is related to tension headaches, showed significant improvement in pain and movement. This suggests that dry needling, a part of Manipulation & Dry Needling, can also be beneficial. While the studies focus on related conditions, they indicate that these treatments can help reduce pain and improve function. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for tension headaches?

Research shows that treatments like transcutaneous electrical nerve stimulation (TENS) and dry needling can help reduce pain and improve movement in conditions similar to tension headaches, such as neck pain and fibromyalgia. Additionally, soft tissue techniques and neural mobilization have been found effective in managing tension-type headaches. ^{1 2 3 4 5}

What safety data exists for treatments involving manipulation, dry needling, and TENS for tension headaches?

The studies reviewed provide safety data for treatments involving manipulation, dry needling, and TENS. These treatments have been evaluated for conditions like cervicogenic headaches, myofascial pain, fibromyalgia, and acute pain. TENS is a non-pharmacological intervention used for pain relief, and studies have shown its effectiveness in combination with other therapies like joint manipulation. Both dry needling and TENS have shown significant improvements in pain and range of motion in patients with neck pain due to myofascial trigger points, indicating their safety and efficacy in similar conditions. ^{1 3 4 6 7}

Is the treatment generally safe for humans?

Transcutaneous Electrical Nerve Stimulation (TENS) is generally considered safe for humans and is used for various pain conditions, including headaches and fibromyalgia, without significant safety concerns. ^{1 3 4 6 8}

Is the treatment of Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise, TENS, Thrust Manipulation, Electric Dry Needling, and Exercise promising for tension headaches?

Yes, this treatment is promising for tension headaches. Studies show that techniques like dry needling and TENS can help reduce pain and improve neck movement. These methods, along with exercises and mobilization, offer a non-drug approach to managing headaches. ^{1 3 9 10 11}

How does the treatment of manipulation and dry needling differ from other treatments for tension headaches?

This treatment is unique because it combines physical therapy techniques like manipulation and massage with dry needling and TENS (a method using electrical currents to relieve pain), offering a non-drug approach that targets muscle trigger points and improves neck movement, which may not be addressed by standard headache medications. ^{1 3 9 10 11}

What is the purpose of this trial?

This trial compares two treatment methods for people with tension headaches. One method uses chiropractic adjustments, needling, and exercise, while the other uses gentle joint movements, massage, exercise, and electrical stimulation. The goal is to see which method works better at reducing headache pain.

Research Team

James Dunning, DPT PhD

Principal Investigator

American Academy of Manipulative Therapy

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[Comparative study on effects of manipulation treatment and transcutaneous electrical nerve stimulation on patients with cervicogenic headache]. [2019]

2. Belgium pubmed.ncbi.nlm.nih.gov

[Exercise therapy in E.N.T]. [2009]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded Pragmatic Trial. [2023]

5. United States 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for acute pain. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Hypoalgesic Effects of Transcutaneous Electrical Nerve Stimulation Combined With Joint Manipulation: A Randomized Clinical Trial. [2021]

8. Netherlands 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The 'dry-needle technique': intramuscular stimulation in tension-type headache. [2017]

10. England 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. [2022]

11. United States 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. [2022]