Chiropractic Spinal Manipulation for Headache

NCT05240547 | Unknown

• 1 other identifier: SMTHA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot and feasibility randomized controlled trial to assess the efficacy of chiropractic spinal manipulative therapy in patients with tension-type and cervicogenic headache.

Conditions

Cervicogenic Headache; Tension-Type Headache

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Pain intensity will be measured by showing patients a numerical rating scale from 0 (no pain at all) to 10 (maximum possible pain)

  4 weeks

• Pain frequency

  Chronic pain patients will describe whether their pain is episodic (pain-free periods of at least 4 week duration) or fluctuating (no pain-free periods of at least 4 week duration)

  4 weeks

Secondary Outcomes (2)

• Pain Catastrophizing Scale

  4 weeks

• Pressure pain thresholds

  4 weeks

Other Outcomes (7)

• Sex

  4 months

• Age

  4 months

• Costs for care

  4 months

Study Arms (2)

Spinal manipulation

EXPERIMENTAL

Spinal manipulative therapy will be delivered to the cervical spine (segments including occiput-atlas to C7-D1) according to the chiropractors' evaluation during each visit. During each session, one or two segments will be manipulated using a high-velocity low-amplitude thrust manipulation (a joint cavitation will be expected, if not, the thrust can repeated once) applied to the segments with the highest motion restriction, as determined by the chiropractor by static and motion palpation of the cervical spine.

Other: Spinal Manipulation

Placebo

PLACEBO COMPARATOR

Sham manipulation will be delivered to the cervical spine (segments including occiput-atlas to C7-D1) according to the chiropractors' evaluation during each visit. During each session, one or two segments will receive a sham manipulation applied to the segments with the highest motion restriction, as determined by the chiropractor by static and motion palpation of the cervical spine. The sham manipulation will consist in a identical contact to the real manipulation, except the thrust will be delivered towards the table, away from the target segment and with the intention to lower the cervical drop piece of the table, which will substitute the joint cavitation noise.

Other: Placebo

Interventions

Spinal Manipulation OTHER

Spinal manipulative therapy delivered to the cervical spine by a chiropractor

Spinal manipulation

Placebo OTHER

Sham manipulative treatment delivered to the cervical spine by a chiropractor

Placebo

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 2 episodes per month of cervicogenic or tension-type headache for at least 3 months. Diagnoses will be determined by case history and physical examination according to the International Headache Society criteria (3rd Edition)

You may not qualify if:

• Having received chiropractic treatment in the previous 12 months
• Diagnosis or frequent symptoms of migraine headaches (symptoms present at least once a month) without an overlapping presentation of cervicogenic or tension-type headache.
• Patients with pathologies affecting the nervous system (MS, tumors, past history of stroke...)
• Contraindications to manual therapy, particularly spinal manipulative therapy (cancer, uncontrolled high blood-pressure, severe cardiovascular conditions)
• Past history of cervical spine surgery
• Pregnancy
• Having being diagnosed with a psychiatric conditions, with the exception of depression and anxiety

Sponsors & Collaborators

• Real Centro Universitario Maria Cristina: lead

Study Sites (1)

Real Centro Universitario María Cristina

El Escorial, Madrid, 28200, Spain

RECRUITING

MeSH Terms

Conditions

Post-Traumatic Headache; Tension-Type Headache

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Carlos Gevers Montoro, DC, MSc

  RCU María Cristina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Torres Gonzalez, BSc

CONTACT

918909435; elisa.torres.quiro@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 15, 2022
• Study Start: February 14, 2022
• Primary Completion: May 30, 2024
• Study Completion: December 14, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)