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De klinische studie NCT06616272 (ConCerv) voor Hersenschudding, Nekpijn is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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Cervical Spine Focused Treatment for Patients With Persistent Concussion Symptoms and Neck Pain (ConCerv)

Recruterend
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De klinische studie NCT06616272 (ConCerv) is een interventioneel studie bij Hersenschudding, Nekpijn met de status recruterend. Het doel is om 40 deelnemers te includeren vanaf 28 augustus 2025. De studie wordt geleid door de Universiteit van Pittsburgh en de voltooiing is gepland op 15 december 2025. Laatste update op ClinicalTrials.gov: 12 november 2025.
Beknopte samenvatting
Assess the feasibility of recruiting, enrolling and randomizing patients with concussion symptoms and neck pain to receive manual therapy and cervical rehabilitative exercises in addition to standard concussion treatment.

In the usual care workflow provided at the participating concussion clinic, cervical spine rehab is not typically introduced until after week 4. The rationale is that neck pain is often a self-limiting condition that may resolve spontaneously, without the need for specific cervical spine rehab.

This study is chiefly focused on feasibility aims that revolve around developing changes to barriers in workflow issues at the participating concussion clinic, that would allow for earlier introduction of cervical spine rehab.

Uitgebreide beschrijving
This is a a single site pilot randomized controlled trial consisting of a total of 40 participants with concussion and neck pain, randomized to one of two groups (n=20 per group):

  1. early cervical spine focused treatment combined with standard concussion care.
  2. standard concussion care alone for 4 weeks, followed by delayed introduction (after 4 weeks) of cervical spine focused treatment (which is the usual care workflow at our clinical partner site.)

Both groups will receive the combination of cervical spine focused treatment and standard concussion care; the only variation being the timing of the introduction of the cervical spine care.

The primary endpoint will be 4 weeks from start of cervical rehabilitation intervention. The secondary would be the point of discharge. The duration of active participation in the study will be 8 weeks for the participants.

Officiële titel

Cervical Spine Focused Treatment for Patients With Persistent Concussion Symptoms and Neck Pain: Pilot Study

Aandoeningen
HersenschuddingNekpijn
Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:
Andere studie-ID's
  • ConCerv
  • STUDY24040157
NCT-ID
NCT06616272
Startdatum (Werkelijk)
2025-08-28
Laatste update geplaatst
2025-11-12
Verwachte einddatum
2025-12-15
Inschrijving (Geschat)
40
Studietype
Interventioneel
FASE
N.v.t.
Status
Recruterend
Trefwoorden
concussion care
cervical rehabilitation
neck pain
Primaire doel
Overige
Toewijzing
Gerandomiseerd
Interventiemodel
Cross-over
Blindering
Enkelblind
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
Actieve comparatorEarly cervical spine focused treatment and standard concussion care
The cervical spine focused treatment will start concurrently with the standard care once the participant is randomized to this group. The participants will receive early cervical spine focused treatment 2x/week for 4 weeks. In addition to the cervical spine focused treatment, this group will also receive standard concussion care interventions individualized to the participant's needs 1x/week concurrently during the same 4-week period of time. After 4 weeks, the participant will discontinue the cervical spine focused treatment but may continue with standard concussion care for an additional 4 weeks (maximum total treatment duration is 8 weeks).
Cervical Rehabilitation
* Manual joint mobilization (Grades I-V) of painful and restricted cervical spine segments. * Supine manual cervical traction to stretch and mobilize the cervical spinal tissues. * Manual soft tissue mobilization of the cervical, upper thoracic and/or shoulder muscles. * Passive stretching of hypertonic muscles and active strengthening of hypotonic muscles. * Motor-control and isometric exercises to activate the deep neck flexors.
Standard Concussion Care
Standard Concussion Care interventions are individualized to each patient and their adjudicated profile(s)/moderating factor(s) and may include any/all of the following: * Behavioral regulation * Vestibular rehabilitation * Oculomotor rehabilitation * Exertion rehabilitation * Pharmacological management * Behavioral sleep intervention * \*Cervical spine rehabilitation (the variable of interest in this study) * Psychotherapy
Actieve comparatorStandard concussion care alone followed by delayed cervical spine focused treatment
Participants randomized to the delayed cervical spine focused treatment group will only receive the standard concussion care (individualized to their needs) 1x/week for the initial 4 weeks. At the 4-week timepoint, the cervical spine focused treatment will be added to the standard concussion care at a frequency of twice a week for 4 weeks. Should a participant be cleared for return to activity prior to the end of the 4-week period, cervical spine focused treatment will be suspended. The maximum total treatment duration is 8 weeks; 1x/week for weeks 1-8 for the standard concussion care and 2x/week for weeks 4-8 for the cervical spine focused treatment.
Cervical Rehabilitation
* Manual joint mobilization (Grades I-V) of painful and restricted cervical spine segments. * Supine manual cervical traction to stretch and mobilize the cervical spinal tissues. * Manual soft tissue mobilization of the cervical, upper thoracic and/or shoulder muscles. * Passive stretching of hypertonic muscles and active strengthening of hypotonic muscles. * Motor-control and isometric exercises to activate the deep neck flexors.
Standard Concussion Care
Standard Concussion Care interventions are individualized to each patient and their adjudicated profile(s)/moderating factor(s) and may include any/all of the following: * Behavioral regulation * Vestibular rehabilitation * Oculomotor rehabilitation * Exertion rehabilitation * Pharmacological management * Behavioral sleep intervention * \*Cervical spine rehabilitation (the variable of interest in this study) * Psychotherapy
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Recruitment rate
Enrolling 6 new participants per month
6 months
Treatment Adherence
Assess the rate of adherence to treatment with a goal of participant attending ≥ 75% (6 of 8) of scheduled visits.
2 months
Conversion Rate
Ratio of concussion patients with neck pain approached about participation or referred for screening to those actually screened. As well as conversion rate of concussion patients screened for participation to those enrolled and randomized.
6 months
Adverse Event Rate
Rates of expected side effects and adverse events
2 months
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Concussion Clinical Profile screen (CP screen)
Patient reported outcome regarding their concussion symptoms. The raw score ranges from 0 to 87. The scale helps identify specific clinical profiles and associated modifiers in concussion patients.
Baseline, 4 week, 8 week
Numeric pain rating scale (NPRS)
Patient reported measure regarding average neck pain over past week. The score range from 0 to 10 where 0 is no pain and 10 is considered the worst pain imaginable.
Baseline, 4 week, 8 week
Neck Disability index (NDI)
Patient reported outcome regarding their neck pain related disability. The scale ranges from 0-50 that are then converted to percentages. The scores are interpreted as: 0-20%: minimal disability; 21-40%: moderate disability; 41-60%: severe disability; and \>60%: complete disability.
Baseline, 4 week, 8 week
Pain, Enjoyment and General Activity Score (PEG)
Patient reported outcome regarding their pain and its interference to enjoyment in life and general activity in the past week. The scale has three individual items that are scored from 0 to 10. The overall score is the average of the three individual item scores rounded to the nearest whole number for clinical use.
Baseline, 4 week, 8 week
Geschiktheidscriteria

Leeftijd van deelnemers
Kind, Volwassene
Minimumleeftijd
12 Years
Geslachten die in aanmerking komen voor de studie
Allen
  • Diagnosed concussion
  • Patient endorses neck pain OR difficulty moving their neck (moderate or severe; score of 2 or 3 for items 16 and 25 from concussion CP screen)
  • Willingness to be randomized
  • 8-90 days post injury
  • English Speaking

  • Previous concussion within the past 6 months
  • Prior history of ischemic/vascular events
  • Previous treatment for current symptoms
  • Prior treatment for neck pain/headaches in the past year
  • Workers' compensation claim and/or litigation associated with injury
  • Diagnosed substance use disorder
  • Prior cervical spine surgery
  • Prior fracture and or dislocation/subluxation of the cervical spine
  • Diagnosed inflammatory arthritis
University of Pittsburgh logoUniversiteit van Pittsburgh542 actieve klinische studies om te verkennen
Verantwoordelijke instantie
Michael Schneider, DC, PhD, Hoofdonderzoeker, Professor, University of Pittsburgh
Centraal Contactpersoon
Contact: Cynthia L Holland, MPH, 4129046126, [email protected]
4 Studielocaties in 3 landen

Pennsylvania

UPMC sports medicine, Pittsburgh, Pennsylvania, 15203, United States
Cynthia L Holland, Contact, 4129046126, [email protected]
Recruterend

Wisconsin

Greenfield Clinic-Children's Wisconsin, Milwaukee, Wisconsin, 53227, United States
Jeff King, DC, Contact, 2628255139, [email protected]
Amy Nader, Contact, 4149557314, [email protected]
Nog niet rekruterend
UPMC Sports Surgery Clinic, Dublin, Ireland
Ciaran Cosgrave, Contact, +353 1 526 2030, [email protected]
Louise Keating, Contact, +353 1 4022259, [email protected]
Nog niet rekruterend
Sports Medicine Northern Ireland, Belfast, United Kingdom
Alan Rankin, Contact, 028 9019 0290, [email protected]
Louise Keating, Contact, +353 1 4022259, [email protected]
Nog niet rekruterend