Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02950909 |
| Other study ID # |
H1472552616890 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2016 |
| Est. completion date |
December 2017 |
Study information
| Verified date |
September 2021 |
| Source |
University of Valencia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary aim of this study therefore is to investigate the effects on pain and disability
of an emphasized exercise program targeting the deep neck extensor semispinalis cervicis and
a general exercise program for all neck extensor muscles in patients with chronic neck pain.
As a secondary aim , pain intensity (VAS), cervical ROM, pressure pain threshold (PPT),
cervical and thoracic posture and self-perceived benefit of treatment (GROC) were measured.
The investigators hypothesized that both exercise programs would have similar effects on pain
alleviation and pain related disability, but that the emphasized exercise program for the
deep semispinalis cervicis would improve its activation more compared to the general exercise
program. The results of this study will be relevant for designing effective
rehabilitation/training programs for patients with chronic neck pain.
Description:
An independent group, repeated-measures study design was adopted to investigate the immediate
effect of two different kinds of intervention: Emphasized exercises targeting the deep
cervical extensors and general exercises targeting all neck extensors. Subjects were
randomized into two exercise groups: the emphasized exercise group in which patients
performed muscle contractions against resistance directly at the neck and the general
exercise group in which the resistance was applied at the head. Sealed opaque envelopes were
used to conceal allocation.
Exercise regimes was of 6-weeks duration and started within one week of the initial
assessment. All subjects received personal instruction and supervision by one experienced
physiotherapist, once a week, for the duration of the whole program.
Subjects received an exercise diary and were requested to practice their respective regime
twice per day for the six-week duration of the trial, without provoking neck pain and with
attention to correct performance of the exercises. Exercises at home occurred for a period of
no longer than 15 to 20 minutes twice per day. Subjects were asked not to seek other
interventions for neck pain during the duration of the study, although usual medication was
not withheld.
All patients performed two static exercises and one dynamic exercise. The only difference
between both groups was the location of the resistance, which was in the lower cervical spine
approximately at level C4 for the emphasized exercise group and at the occiput for the
general exercise group.
1. Patients in the emphasized exercise group performed exercises emphasizing the deep
cervical extensor muscles applying a resistance at the level of the vertebral arch of C4
either therapeutically with the therapist's fingers or as a home exercise with the aid
of a towel or belt. These exercises were performed in sitting and standing in front of a
table propped up on both forearms. In the latter position, a dynamic exercise was added
moving the head from maximal flexion to maximal extension keeping the gaze fixed at an
object lying between both elbows hoping to activate more the extensors in the lower
cervical spine.
2. Patients in the general exercise group performed exercises targeting all cervical
extensor muscles including the superficial ones applying resistance at the head pushing
against a wall or the therapist's hand or as a home exercise with the aid of a towel. As
in the other group, these exercises were performed in sitting and standing in front of a
table propped up on both forearms. In the latter position, the same dynamic exercise was
added as in the other group with the only difference that the gaze was fixed at an
object lying between both hands hoping to activate all cervical extensors.
The dosage for both exercise regimes required maximal muscle activation of the patient
because it was shown that at this dosage the emphasized exercise results in muscle activation
of about 20% to 25% MVC (Maximum Voluntary Contraction) and the general exercise of about 50%
MVC (Schomacher et al., 2015). Patients were asked therefore to perform the exercises at
their individual maximal force for a short time without provoking any pain neither during nor
after the exercise. That is, submaximal effort without evoking pain during and after the
exercises was used.
All exercises were repeated each for 3 sets with a break of 1-2 minutes between the sets. The
two static exercises consisted of 6 repetitions of 6 seconds hold in each position with 6
seconds rest between each contraction. The dynamic exercise was performed with 6 repetitions
through the whole range of motion with 2-3 seconds for each repetition without any rest
between the repetitions. A break between the repetitions was added if necessary to avoid pain
(Table 1). Patients repeated the exercise session one time per week under supervision of a
physiotherapist, during 6 weeks. In addition, patients performed the exercise session twice
per day seven days per week at home. Each exercise session lasted about 20 - 25 minutes.
